B. Braun Medical, Inc. Locking Tear-Away Sheath Introducer Product Line. ACCUGUIDE SINGLE LUMEN 4FR PICC P460K 5/; P560K PICC 5FR W/INTRO KIT; MTI451845 4.5FR MINI T/A; MTI551845 5.5FR MINI TA; MTI651845 6.5FR MINI T/A; P460OTW SNGL LUM PICC W/MTI; P4552K DBL LUM PICC INTRO KIT; P5552K DBL LUM PICC INTRO KIT; P4552KOTW DBL LUM OTW PICC INTRO KIT LF; LOCKING T/A INTRODUCERS 11FR; INTRADYN TEAR-AWAY INTRODUCER 4F; INTRADYN TEAR-AWAY INTRODUCER 5F; INTRADYN TEAR-AWAY INTRODUCER 6F; INTRADYN TEAR-AWAY INTRODUCER 7F; INT Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Locking Tear-Away Sheath Introducer Product Line. ACCUGUIDE SINGLE LUMEN 4FR PICC P460K 5/; P560K PICC 5FR W/INTRO KIT; MTI451845 4.5FR MINI T/A; MTI551845 5.5FR MINI TA; MTI651845 6.5FR MINI T/A; P460OTW SNGL LUM PICC W/MTI; P4552K DBL LUM PICC INTRO KIT; P5552K DBL LUM PICC INTRO KIT; P4552KOTW DBL LUM OTW PICC INTRO KIT LF; LOCKING T/A INTRODUCERS 11FR; INTRADYN TEAR-AWAY INTRODUCER 4F; INTRADYN TEAR-AWAY INTRODUCER 5F; INTRADYN TEAR-AWAY INTRODUCER 6F; INTRADYN TEAR-AWAY INTRODUCER 7F; INT
Brand
B. Braun Medical, Inc.
Lot Codes / Batch Numbers
Catalog #, Lot Numbers: 333603--Lot #s 0060529076, 0060542787, 0060551433, 0060552115, 0060553837, 0060562411, 0060702019, 0060702049. 333604--0060553838, 0060708443, 0060713806. 333606--0060472888, 0060516047, 0060583876, 0060710305, 0060710306, 0060751880. 333608--0060569225, 0060703806, 0060729030, 3360734585. 333609--0060703808. 333610--0060738852. 333612--0060542791, 0060549251, 0060553963, 0060702064, 0060708037. 333613--0060549252, 0060553909, 0060702069, 0060702071, 0060702074. 333614--0060521374, 0060551766, 0060702082. 610064--0060709374. 610100--0060702177, 0060761533. 610101--0060702179. 610102--0060710159. 610103--0060713850. 610104--0060734898, 0060741005. 610105--0060722688, 0060710792. 610152--0060710794. 610153--0060551073, 0060568835. 610155--0060708367, 0060708367, 0060742089. 610177--0060558435, 0060707652, 0060709662, 0060746191, 0060766191. 610264--0060707534. 610407--0060732173. 610559--0060523821, 0060555811, 0060572434, 0060709663, 0060726953, 0060733425. 610570--0060726955. 610652--0060707368, 0060737064. 610654--006545559, 0060552179, 0060744541. 610811--0060473107, 0060473108, 0060560316, 0060738144. 610812--0060726992. 610813--0060757144. 610814--0060572400, 0060732297. 610815--0060538361, 0060542288, 0060757084. 610816--0060520549, 0060523748, 0060538364, 0060572403, 0060710820, 0060722731. 610817--0060544240, 0060545503, 0060569903, 0060571978. 610818--0060528048, 0060561924, 0060709739, 0060726994. 610819--0060545504, 0060709740, 0060727002. 610820--0060707651. 610830--0060712212, 0060742386. 610843--0060709735. 610894--0060544824, 0060545508, 0060557624, 0060707071, 0060715230, 0060728009, 0060752044, 0060752045. 610916--0060710874, 0060710875. 610923--0060497968, 0060545511, 0060754189, 0060516182, 0060545512, 0060569910. 610974--0060719256. 610976--0060517487, 0060551012, 0060564301, 0060571977, 0060709065, 0060719972. 610982--0060725523. 611109--0060523767, 0060545524, 0060551019, 0060555703, 0060706362, 0060707365, 0060709725, 0060716210. 611172--0060706038. 611840--0060519177, 0060540542, 0060545484, 0060552193, 0060564379, 0060707285, 0060711192, 0060722451. 612001--0060528366, 0060541715, 0060709669. 612122--0060752209. 612124--0060755565, 0060759158. 614006--0060545527, 0060545529, 0060548273, 0060555801, 0060564933, 0060569911, 0060572409, 0060706138, 0060706158, 0060706169, 0060706174, 0060709679, 0060749179. 614007--0060473083, 0060494998, 0060503536, 0060507452, 0060517491, 0060545530, 0060545531, 0060551054, 0060564304, 0060564934, 0060566303, 0060566304, 0060566305, 0060712277, 0060720315, 0060724332, 0060726782, 0060750181. 614008--0060545533, 0060548274, 0060554892, 0060555802, 0060564936, 0060568832, 0060569912, 0060572414, 0060576479, 0060576483, 0060576484, 0060712278, 0060712279, 0060712280, 0060737734. 614012--0060747064. 614037--0060547187, 0060735870. 614100--0060709646, 0060709647, 0060715276, 0060720258, 0060521185, 0060536288, 0060538205, 0060551057, 0060560474, 0060572417. 614101--0060709664, 0060709667, 0060715113. 614102--0060562423, 0060710927. 614104--0060580188, 0060707545. 614400--0060588319, 0060707536, 0060707537, 0060707538, 0060712281, 0060722450, 00607727033, 0060749069. 610107A--0060702191, 0060746124. 610154A--0060709726. 7B2807--0060709702, 0060709703, 0060709704, 0060709705, 0060709709, 0060709710, 0060709711, 0060709719, 0060749170. 7C2100--0060707500, 0060707501, 0060709659. 7C6311--0060482936, 0060489182, 0060496750, 0060505790, 0060506316, 0060523417, 006055541633, 0060543824, 0060543825, 0060543826, 0060548258, 0060555712, 0060557290, 0060561310, 0060578814, 0060710970, 0060720149, 0060726624. 7M3882--0060551059, 0060572130, 0060710976, 0060738147, 0060746766. 7M3883--0060707663, 0060725281.
Products Sold
Catalog #, Lot Numbers: 333603--Lot #s 0060529076,0060542787, 0060551433, 0060552115, 0060553837, 0060562411, 0060702019, 0060702049. 333604--0060553838, 0060708443, 0060713806. 333606--0060472888, 0060516047, 0060583876, 0060710305, 0060710306, 0060751880. 333608--0060569225, 0060703806, 0060729030, 3360734585. 333609--0060703808. 333610--0060738852. 333612--0060542791, 0060549251, 0060553963, 0060702064, 0060708037. 333613--0060549252, 0060553909, 0060702069, 0060702071, 0060702074. 333614--0060521374, 0060551766, 0060702082. 610064--0060709374. 610100--0060702177, 0060761533. 610101--0060702179. 610102--0060710159. 610103--0060713850. 610104--0060734898, 0060741005. 610105--0060722688, 0060740847. 610106--0060702186. 610108--0060702192. 610109--0060713856. 610112--0060719604. 610113--0060723081. 610145--0060570243. 610146--0060560608. 610150--0060551068. 610151--0060707659, 0060710792. 610152--0060710794. 610153--0060551073, 0060568835. 610155--0060708367, 0060708367, 0060742089. 610177--0060558435, 0060707652, 0060709662, 0060746191, 0060766191. 610264--0060707534. 610407--0060732173. 610559--0060523821, 0060555811, 0060572434, 0060709663, 0060726953, 0060733425. 610570--0060726955. 610652--0060707368, 0060737064. 610654--006545559, 0060552179, 0060744541. 610811--0060473107, 0060473108, 0060560316, 0060738144. 610812--0060726992. 610813--0060757144. 610814--0060572400, 0060732297. 610815--0060538361, 0060542288, 0060757084. 610816--0060520549, 0060523748, 0060538364, 0060572403, 0060710820, 0060722731. 610817--0060544240, 0060545503, 0060569903, 0060571978. 610818--0060528048, 0060561924, 0060709739, 0060726994. 610819--0060545504, 0060709740, 0060727002. 610820--0060707651. 610830--0060712212, 0060742386. 610843--0060709735. 610894--0060544824, 0060545508, 0060557624, 0060707071, 0060715230, 0060728009, 0060752044, 0060752045. 610916--0060710874, 0060710875. 610923--0060497968, 0060545511, 0060754189, 0060516182, 0060545512, 0060569910. 610974--0060719256. 610976--0060517487, 0060551012, 0060564301, 0060571977, 0060709065, 0060719972. 610982--0060725523. 611109--0060523767, 0060545524, 0060551019, 0060555703, 0060706362, 0060707365, 0060709725, 0060716210. 611172--0060706038. 611840--0060519177, 0060540542, 0060545484, 0060552193, 0060564379, 0060707285, 0060711192, 0060722451. 612001--0060528366, 0060541715, 0060709669. 612122--0060752209. 612124--0060755565, 0060759158. 614006--0060545527, 0060545529, 0060548273, 0060555801, 0060564933, 0060569911, 0060572409, 0060706138, 0060706158, 0060706169, 0060706174, 0060709679, 0060749179. 614007--0060473083, 0060494998, 0060503536, 0060507452, 0060517491, 0060545530, 0060545531, 0060551054, 0060564304, 0060564934, 0060566303, 0060566304, 0060566305, 0060712277, 0060720315, 0060724332, 0060726782, 0060750181. 614008--0060545533, 0060548274, 0060554892, 0060555802, 0060564936, 0060568832, 0060569912, 0060572414, 0060576479, 0060576483, 0060576484, 0060712278, 0060712279, 0060712280, 0060737734. 614012--0060747064. 614037--0060547187, 0060735870. 614100--0060709646, 0060709647, 0060715276, 0060720258, 0060521185, 0060536288, 0060538205, 0060551057, 0060560474, 0060572417. 614101--0060709664, 0060709667, 0060715113. 614102--0060562423, 0060710927. 614104--0060580188, 0060707545. 614400--0060588319, 0060707536, 0060707537, 0060707538, 0060712281, 0060722450, 00607727033, 0060749069. 610107A--0060702191, 0060746124. 610154A--0060709726. 7B2807--0060709702, 0060709703, 0060709704, 0060709705, 0060709709, 0060709710, 0060709711, 0060709719, 0060749170. 7C2100--0060707500, 0060707501, 0060709659. 7C6311--0060482936, 0060489182, 0060496750, 0060505790, 0060506316, 0060523417, 006055541633, 0060543824, 0060543825, 0060543826, 0060548258, 0060555712, 0060557290, 0060561310, 0060578814, 0060710970, 0060720149, 0060726624. 7M3882--0060551059, 0060572130, 0060710976, 0060738147, 0060746766. 7M3883--0060707663, 0060725281.
B. Braun Medical, Inc. is recalling Locking Tear-Away Sheath Introducer Product Line. ACCUGUIDE SINGLE LUMEN 4FR PICC P460K 5/; P560K due to Reports that the tearaway introducer sheaths have cracked hubs/handles and/or improper peeling of the sheath during use.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reports that the tearaway introducer sheaths have cracked hubs/handles and/or improper peeling of the sheath during use.
Recommended Action
Per FDA guidance
Recall letters shere sent out to the firm''s customers on 5/27/2005 via US Mail, Return Receipt Requested.
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 noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026