Instrumed International, Inc. An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry Surgical, CareFusion, Boss Instruments, Phoenix Instruments, Autobahn Surgical, Echo Instruments, Millennium Surgical, B.B.M. Surgical Instruments, Stealth Surgical, Medline Industries, Medsaver M S I Precision, and Surgical Direct brand names. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry Surgical, CareFusion, Boss Instruments, Phoenix Instruments, Autobahn Surgical, Echo Instruments, Millennium Surgical, B.B.M. Surgical Instruments, Stealth Surgical, Medline Industries, Medsaver M S I Precision, and Surgical Direct brand names.
Brand
Instrumed International, Inc.
Lot Codes / Batch Numbers
1) Instrumed Product Name: Valvulotome 6 1/4" Retrograde, Instrumed Product Number: 500-05626, Trade Name: Symmetry Surgical, Symmetry Surgical Product Name: Valvulotome 6 1/4" Retrograde, Symmetry Surgical Item Number: 55-8685, Lot Numbers: 030412, 060413, 070513. 2) Instrumed Product Name: Valvulotome 6 1/4" Retrograde, Instrumed Product Number: 500-05626, Trade Name: CareFusion, CareFusion Product Name: Valvulotome 6 1/4" Retrograde, CareFusion Item Number: 55-8685, Lot Number: 070513. 3) Instrumed Product Name: Valvulotome 6 1/4" Retrograde, Instrumed Product Number: 500-05626, Trade Name: Boss Instruments, Boss Instruments Product Name: Valvulotome, retro, 6 1/4", Boss Instruments Item Number: 65-7048, Lot Numbers: 030412, 060413, 070513, 110411. 4) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle, Instrumed Product Number: 500-05631, Trade Name: Phoenix Instruments, Phoenix Instruments Product Name: Valvulotome, retro, 9 1/4" reverse angle, Phoenix Instruments Item Number: 155-8680, Lot Numbers: 020114, 050114, 060112, 120312. 5) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle, Instrumed Product Number: 500-05631, Trade Name: Autobahn Surgical, Autobahn Surgical Product Name: Valvulotome, retro, 9 1/4" reverse angle, Autobahn Surgical Item Number: 352614A, Lot Number: 120312. 6) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle, Instrumed Product Number: 500-05631, Trade Name: Echo Instruments, Echo Instruments Product Name: Valvulotome, retro, 9 1/4" reverse angle, Echo Instruments Item Number: 558-690, Lot Number: 070513. 7) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle, Instrumed Product Number: 500-05631, Trade Name: Symmetry Surgical, Symmetry Surgical Product Name: Valvulotome, retro, 9 1/4" reverse angle, Symmetry Surgical Item Number: 155-8680, Lot Numbers: 020114, 030314, 050114, 060112, 060214, 070513, 110212, 120312. 8) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle, Instrumed Product Number: 500-05631, Trade Name: Millennium Surgical, Millennium Surgical Product Name: Valvulotome, retro, 9 1/4" reverse angle, Millennium Surgical Item Number: 9-68680, Lot Numbers: 030314, 070513, 120312. 9) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle, Instrumed Product Number: 500-05631, Trade Name: B.B.M. Surgical Instruments, B.B.M. Surgical Instruments Product Name: Valvulotome, retro, 9 1/4" reverse angle, B.B.M. Surgical Instruments Item Number: BBM8680, Lot Number: 060112. 10) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle, Instrumed Product Number: 500-05631, Trade Name: Stealth Surgical, Stealth Surgical Product Name: Valvulotome, retro, 9 1/4" reverse angle, Stealth Surgical Item Number: SSV21161, Lot Numbers: 040513, 050114, 060112, 070513, 120312. 11) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle, Instrumed Product Number: 500-05631, Trade Name: CareFusion, CareFusion Product Name: Valvulotome, retro, 9 1/4" reverse angle, CareFusion Item Number: VM76-8161, Lot Numbers: 020114, 030314, 050114, 070513, 110212, 120312. 12) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle, Instrumed Product Number: 500-05631, Trade Name: Boss Instruments, Boss Instruments Product Name: Valvulotome, retro, 9 1/4", Boss Instruments Item Number: 65-7050, Lot Numbers: 050214, 060112, 060214. 13) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle, Instrumed Product Number: 500-05631, Trade Name: Medline Industries, Medline Industries Product Name: VALVULOTOME, LEATHER, ANTEGRADE, 2.9 TIP 9.5", Medline Industries Item Number: MDG0416536, Lot Number: 070513. 14) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm, Instrumed Product Number: 500-05636, Trade Name: Phoenix Instruments, Phoenix Instruments Product Name: Valvulotome, retro, 12" cut edge 2 mm, Phoenix Instruments Item Number: 155-8682, Lot Number: 070212. 15) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm, Instrumed Product Number: 500-05636, Trade Name: Autobahn Surgical, Autobahn Surgical Product Name: Valvulotome, retro, 12" cut edge 2 mm, Autobahn Surgical Item Number: 352613A, Lot Number: 070212. 16) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm, Instrumed Product Number: 500-05636, Trade Name: Medsaver M S I Precision, Medsaver M S I Precision Product Name: Valvulotome, retro, 12" cut edge 2 mm, Medsaver M S I Precision Item Number: 421637J, Lot Number: 110212. 17) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm, Instrumed Product Number: 500-05636, Trade Name: Symmetry Surgical, Symmetry Surgical Product Name: Valvulotome, retro, 12" cut edge 2 mm, Symmetry Surgical Item Number: 55-8682, Lot Numbers: 020413, 030314, 050114, 060413, 070212, 100313, 110212. 18) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm, Instrumed Product Number: 500-05636, Trade Name: Surgical Direct, Surgical Direct Product Name: Valvulotome, retro, 12" cut edge 2 mm, Surgical Direct Item Number: 9-68680001, Lot Numbers: 060413, 100313. 19) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm, Instrumed Product Number: 500-05636, Trade Name: Millennium Surgical, Millennium Surgical Product Name: Valvulotome, retro, 12" cut edge 2 mm, Millennium Surgical Item Number: SD8121.103, Lot Numbers: 050114, 060413. 20) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm, Instrumed Product Number: 500-05636, Trade Name: CareFusion, CareFusion Product Name: Valvulotome, retro, 12" cut edge 2 mm, CareFusion Item Number: VM76-8163, Lot Numbers: 020413, 030314, 050114, 060413, 070212, 080111, 100313, 110212. 21) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm, Instrumed Product Number: 500-05636, Trade Name: Boss Instruments, Boss Instruments Product Name: Valvulotome, retro, 12", Boss Instruments Item Number: 65-7052, Lot Numbers: 050114, 060413. 22) Instrumed Product Name: Valvulotome, ante, 6 1/4", Instrumed Product Number: 500-05656, Trade Name: Phoenix Instruments, Phoenix Instruments Product Name: Valvulotome, ante, 6 1/4", Phoenix Instruments Item Number: 155-8681, Lot Number: 080111. 23) Instrumed Product Name: Valvulotome, ante, 6 1/4", Instrumed Product Number: 500-05656, Trade Name: Symmetry Surgical, Symmetry Surgical Product Name: Valvulotome, ante, 6 1/4", Symmetry Surgical Item Number: 55-8681, Lot Numbers: 030314, 040214, 060413, 070212, 080111, 120413. 24) Instrumed Product Name: Valvulotome, ante, 6 1/4", Instrumed Product Number: 500-05656, Trade Name: Millennium Surgical, Millennium Surgical Product Name: Valvulotome, ante, 6 1/4", Millennium Surgical Item Number: 9-68681, Lot Numbers: 040214, 060413. 25) Instrumed Product Name: Valvulotome, ante, 6 1/4", Instrumed Product Number: 500-05656, Trade Name: B.B.M. Surgical Instruments, B.B.M. Surgical Instruments Product Name: Valvulotome, ante, 6 1/4", B.B.M. Surgical Instruments Item Number: BBM8681, Lot Number: 050312. 26) Instrumed Product Name: Valvulotome, ante, 6 1/4", Instrumed Product Number: 500-05656, Trade Name: Stealth Surgical, Stealth Surgical Product Name: Valvulotome, ante, 6 1/4", Stealth Surgical Item Number: SSV21162, Lot Numbers: 060413, 070212. 27) Instrumed Product Name: Valvulotome, ante, 6 1/4", Instrumed Product Number: 500-05656, Trade Name: CareFusion, CareFusion Product Name: Valvulotome, ante, 6 1/4", CareFusion Item Number: VM76-8162, Lot Numbers: 030314, 040214, 060413, 120413. 28) Instrumed Product Name: Valvulotome, ante, 6 1/4", Instrumed Product Number: 500-05656, Trade Name: Medline Industries, Medline Industries Product Name: Valvulotome, ante, 6 1/4", Medline Industries Item Number: MDG546940, Lot Number: 060413. 29) Instrumed Product Name: Valvulotome, ante, 7", Instrumed Product Number: 500-05660, Trade Name: Boss Instruments, Boss Instruments Product Name: Valvulotome, ante, 7", Boss Instruments Item Number: 65-7051-7, Lot Numbers: 050314, 100313. 30) Instrumed Product Name: Valvulotome 9 1/4" Antegrade, Instrumed Product Number: 500-05664, Trade Name: Autobahn Surgical, Autobahn Surgical Product Name: Valvulotome 9 1/4" Antegrade, Autobahn Surgical Item Number: 352612A, Lot Number: 090412. 31) Instrumed Product Name: Valvulotome 9 1/4" Antegrade, Instrumed Product Number: 500-05664, Trade Name: Symmetry Surgical, Symmetry Surgical Product Name: Valvulotome 9 1/4" Antegrade, Symmetry Surgical Item Number: 55-8684, Lot Numbers: 020311, 070513, 090412. 32) Instrumed Product Name: Valvulotome 9 1/4" Antegrade, Instrumed Product Number: 500-05664, Trade Name: CareFusion, CareFusion Product Name: Valvulotome 9 1/4" Antegrade, CareFusion Item Number: VM76-8150, Lot Numbers: 070513, 090412, 100513. 33) Instrumed Product Name: Valvulotome 9 1/4" Antegrade, Instrumed Product Number: 500-05664, Trade Name: Boss Instruments, Boss Instruments Product Name: Valvulotome, ante, 9 1/4", Boss Instruments Item Number: 65-7049, Lot Number: 070513. 34) Instrumed Product Name: Valvulotome 9 1/4" Antegrade, Instrumed Product Number: 500-05664, Trade Name: Medline Industries, Medline Industries Product Name: Valvulotome, Antegrade 9 1/4", Medline Industries Item Number: MDG0416566, Lot Number: 090412. 35) Instrumed Product Name: Valvulotome Antegrade, 12", Instrumed Product Number: 500-05669, Trade Name: Boss Instruments, Boss Instruments Product Name: Valvulotome Antegrade, 12", Boss Instruments Item Number: 65-7053, Lot Numbers: 020114, 050114, 050312, 060413, 090412. 36) Instrumed Product Name: Valvulotome Antegrade, 12", Instrumed Product Number: 500-05669, Trade Name: Phoenix Instruments, Phoenix Instruments Product Name: Valvulotome Antegrade, 12", Phoenix Instruments Item Number: 155-8683, Lot Number: 060413. 37) Instrumed Product Name: Valvulotome Antegrade, 12", Instrumed Product Number: 500-05669, Trade Name: Symmetry Surgical, Symmetry Surgical Product Name: Valvulotome Antegrade, 12", Symmetry Surgical Item Number: 55-8683, Lot Number: 020114, 050312, 060413.
Products Sold
1) Instrumed Product Name: Valvulotome 6 1/4" Retrograde; Instrumed Product Number: 500-05626; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Valvulotome 6 1/4" Retrograde; Symmetry Surgical Item Number: 55-8685; Lot Numbers: 030412, 060413, 070513. 2) Instrumed Product Name: Valvulotome 6 1/4" Retrograde; Instrumed Product Number: 500-05626; Trade Name: CareFusion; CareFusion Product Name: Valvulotome 6 1/4" Retrograde; CareFusion Item Number: 55-8685; Lot Number: 070513. 3) Instrumed Product Name: Valvulotome 6 1/4" Retrograde; Instrumed Product Number: 500-05626; Trade Name: Boss Instruments; Boss Instruments Product Name: Valvulotome, retro, 6 1/4"; Boss Instruments Item Number: 65-7048; Lot Numbers: 030412, 060413, 070513, 110411. 4) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: Valvulotome, retro, 9 1/4" reverse angle; Phoenix Instruments Item Number: 155-8680; Lot Numbers: 020114, 050114, 060112, 120312. 5) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: Autobahn Surgical; Autobahn Surgical Product Name: Valvulotome, retro, 9 1/4" reverse angle; Autobahn Surgical Item Number: 352614A; Lot Number: 120312. 6) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: Echo Instruments; Echo Instruments Product Name: Valvulotome, retro, 9 1/4" reverse angle; Echo Instruments Item Number: 558-690; Lot Number: 070513. 7) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Valvulotome, retro, 9 1/4" reverse angle; Symmetry Surgical Item Number: 155-8680; Lot Numbers: 020114, 030314, 050114, 060112, 060214, 070513, 110212, 120312. 8) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Valvulotome, retro, 9 1/4" reverse angle; Millennium Surgical Item Number: 9-68680; Lot Numbers: 030314, 070513, 120312. 9) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: B.B.M. Surgical Instruments; B.B.M. Surgical Instruments Product Name: Valvulotome, retro, 9 1/4" reverse angle; B.B.M. Surgical Instruments Item Number: BBM8680; Lot Number: 060112. 10) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Valvulotome, retro, 9 1/4" reverse angle; Stealth Surgical Item Number: SSV21161; Lot Numbers: 040513, 050114, 060112, 070513, 120312. 11) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: CareFusion; CareFusion Product Name: Valvulotome, retro, 9 1/4" reverse angle; CareFusion Item Number: VM76-8161; Lot Numbers: 020114, 030314, 050114, 070513, 110212, 120312. 12) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: Boss Instruments; Boss Instruments Product Name: Valvulotome, retro, 9 1/4"; Boss Instruments Item Number: 65-7050 ; Lot Numbers: 050214, 060112, 060214. 13) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: Medline Industries; Medline Industries Product Name: VALVULOTOME, LEATHER, ANTEGRADE, 2.9 TIP 9.5"; Medline Industries Item Number: MDG0416536; Lot Number: 070513. 14) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm; Instrumed Product Number: 500-05636; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: Valvulotome, retro, 12" cut edge 2 mm; Phoenix Instruments Item Number: 155-8682; Lot Number: 070212. 15) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm; Instrumed Product Number: 500-05636; Trade Name: Autobahn Surgical; Autobahn Surgical Product Name: Valvulotome, retro, 12" cut edge 2 mm; Autobahn Surgical Item Number: 352613A; Lot Number: 070212. 16) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm; Instrumed Product Number: 500-05636; Trade Name: Medsaver M S I Precision; Medsaver M S I Precision Product Name: Valvulotome, retro, 12" cut edge 2 mm; Medsaver M S I Precision Item Number: 421637J; Lot Number: 110212. 17) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm; Instrumed Product Number: 500-05636; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Valvulotome, retro, 12" cut edge 2 mm; Symmetry Surgical Item Number: 55-8682; Lot Numbers: 020413, 030314, 050114, 060413, 070212, 100313, 110212. 18) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm; Instrumed Product Number: 500-05636; Trade Name: Surgical Direct; Surgical Direct Product Name: Valvulotome, retro, 12" cut edge 2 mm; Surgical Direct Item Number: 9-68680001; Lot Numbers: 060413, 100313. 19) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm; Instrumed Product Number: 500-05636; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Valvulotome, retro, 12" cut edge 2 mm; Millennium Surgical Item Number: SD8121.103; Lot Numbers: 050114, 060413. 20) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm; Instrumed Product Number: 500-05636; Trade Name: CareFusion; CareFusion Product Name: Valvulotome, retro, 12" cut edge 2 mm; CareFusion Item Number: VM76-8163; Lot Numbers: 020413, 030314, 050114, 060413, 070212, 080111, 100313, 110212. 21) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm; Instrumed Product Number: 500-05636; Trade Name: Boss Instruments; Boss Instruments Product Name: Valvulotome, retro, 12"; Boss Instruments Item Number: 65-7052; Lot Numbers: 050114, 060413. 22) Instrumed Product Name: Valvulotome, ante, 6 1/4"; Instrumed Product Number: 500-05656; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: Valvulotome, ante, 6 1/4"; Phoenix Instruments Item Number: 155-8681; Lot Number: 080111. 23) Instrumed Product Name: Valvulotome, ante, 6 1/4"; Instrumed Product Number: 500-05656; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Valvulotome, ante, 6 1/4"; Symmetry Surgical Item Number: 55-8681; Lot Numbers: 030314, 040214, 060413, 070212, 080111, 120413. 24) Instrumed Product Name: Valvulotome, ante, 6 1/4"; Instrumed Product Number: 500-05656; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Valvulotome, ante, 6 1/4"; Millennium Surgical Item Number: 9-68681; Lot Numbers: 040214, 060413. 25) Instrumed Product Name: Valvulotome, ante, 6 1/4"; Instrumed Product Number: 500-05656; Trade Name: B.B.M. Surgical Instruments; B.B.M. Surgical Instruments Product Name: Valvulotome, ante, 6 1/4"; B.B.M. Surgical Instruments Item Number: BBM8681; Lot Number: 050312. 26) Instrumed Product Name: Valvulotome, ante, 6 1/4"; Instrumed Product Number: 500-05656; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Valvulotome, ante, 6 1/4"; Stealth Surgical Item Number: SSV21162; Lot Numbers: 060413, 070212. 27) Instrumed Product Name: Valvulotome, ante, 6 1/4"; Instrumed Product Number: 500-05656; Trade Name: CareFusion; CareFusion Product Name: Valvulotome, ante, 6 1/4"; CareFusion Item Number: VM76-8162; Lot Numbers: 030314, 040214, 060413, 120413. 28) Instrumed Product Name: Valvulotome, ante, 6 1/4"; Instrumed Product Number: 500-05656; Trade Name: Medline Industries; Medline Industries Product Name: Valvulotome, ante, 6 1/4"; Medline Industries Item Number: MDG546940; Lot Number: 060413. 29) Instrumed Product Name: Valvulotome, ante, 7"; Instrumed Product Number: 500-05660; Trade Name: Boss Instruments; Boss Instruments Product Name: Valvulotome, ante, 7"; Boss Instruments Item Number: 65-7051-7; Lot Numbers: 050314, 100313. 30) Instrumed Product Name: Valvulotome 9 1/4" Antegrade; Instrumed Product Number: 500-05664; Trade Name: Autobahn Surgical; Autobahn Surgical Product Name: Valvulotome 9 1/4" Antegrade; Autobahn Surgical Item Number: 352612A; Lot Number: 090412. 31) Instrumed Product Name: Valvulotome 9 1/4" Antegrade; Instrumed Product Number: 500-05664; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Valvulotome 9 1/4" Antegrade; Symmetry Surgical Item Number: 55-8684; Lot Numbers: 020311, 070513, 090412. 32) Instrumed Product Name: Valvulotome 9 1/4" Antegrade; Instrumed Product Number: 500-05664; Trade Name: CareFusion; CareFusion Product Name: Valvulotome 9 1/4" Antegrade; CareFusion Item Number: VM76-8150; Lot Numbers: 070513, 090412, 100513. 33) Instrumed Product Name: Valvulotome 9 1/4" Antegrade; Instrumed Product Number: 500-05664; Trade Name: Boss Instruments; Boss Instruments Product Name: Valvulotome, ante, 9 1/4"; Boss Instruments Item Number: 65-7049; Lot Number: 070513. 34) Instrumed Product Name: Valvulotome 9 1/4" Antegrade; Instrumed Product Number: 500-05664; Trade Name: Medline Industries; Medline Industries Product Name: Valvulotome, Antegrade 9 1/4" ; Medline Industries Item Number: MDG0416566; Lot Number: 090412. 35) Instrumed Product Name: Valvulotome Antegrade, 12"; Instrumed Product Number: 500-05669; Trade Name: Boss Instruments; Boss Instruments Product Name: Valvulotome Antegrade, 12" ; Boss Instruments Item Number: 65-7053; Lot Numbers: 020114, 050114, 050312, 060413, 090412. 36) Instrumed Product Name: Valvulotome Antegrade, 12"; Instrumed Product Number: 500-05669; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: Valvulotome Antegrade, 12" ; Phoenix Instruments Item Number: 155-8683; Lot Number: 060413. 37) Instrumed Product Name: Valvulotome Antegrade, 12"; Instrumed Product Number: 500-05669; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Valvulotome Antegrade, 12" ; Symmetry Surgical Item Number: 55-8683; Lot Number: 020114, 050312, 060413.
Instrumed International, Inc. is recalling An external vein stripper is an extravascular device used to remove a section of a vein sold under t due to The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, . This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026