Aquapak Nebulizer (Teleflex) – Packaging Seal Risk (2014)
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
Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adaptor, Intl, Product No. 404128; Aqauapak 428 SW, 440 ML W/028 Adaptor, Intl, Product No. 404428; Aquapak 728 SW, 760 ML W/028 Adaptor, Product No. 037-28; Aquapak SW/EAU Sterile, 760 ML W/Adaptor, Product No. 037-28C; Aquapak 728 SW, 760 ML W/28 Adaptor, French, Product No. 037-02F; Aquapak 733 SW, 760 ML W/033 Adaptor, Product No. 037-33; Aquapak 735 HNS, 760 ML W/028 Adaptor, Product No. 037-35;
Brand
Teleflex Medical
Lot Codes / Batch Numbers
Product No. 403728, Lot #104120, 114120, 132120, 120120, 155120, 158120, 144120, 164120, 008130, 013130, 023130, 035130, 038130, 049130, 060130, 072130, 054130, 100130, 115130, 128130, 142130 & 020140, Product No. 404128, Lot #065123, 068123, 051123, 077123, 060123, 087123, 005133, 082123, 035133, 029133, 048133, 053133, 056133, 063133, 068133, 076133, 083133, 055123 & 052123, Product No. 404428, Lot #041124, 080124, 002134, 085124, 009134, 019134, 025134, 035134, 049134, 039134, 044134, 056134, 061134, 060134, 003144 & 046124, Product No. 037-28, Lot #083120, 069120, 081120, 068120, 050120, 024120, 023120, 030120, 040120, 042120, 031120, 041120, 051120, 049120, 053120, 052120, 064120, 070120, 071120, 075120, 072120, 078120, 077120, 080120, 034123, 129120, 082120, 084120, 079120, 067120, 076120, 092120, 090120, 094120, 096120, 085120, 091120, 131120, 130120, 095120, 133120, 138120, 097120, 145120, 098120, 134120, 139120, 147120, 146120, 141120, 151120, 152120, 153120, 157120, 159120, 160120, 173120, 166120, 167120, 172120, 174120, 004130, 002130, 177120, 007130, 006130, 005130, 015130, 019130, 010130, 011130, 017130, 016130, 020130, 018130, 021130, 033130, 022130, 024130, 025130, 026130, 036130, 028130, 032130, 027130, 040130, 051130, 041130, 042130, 050130, 052130, 062130, 063130, 064130, 066130, 067130, 077130, 073130, 074130, 075130, 078130, 089130, 118130, 090130, 091130, 119130, 092130, 102130, 103130, 104130, 113130, 110130, 111130, 112130, 114130 & 117130, Product No. 037-28C, Lot #073120, 103120, 093120, 142120, 162120, 012130, 055120, 061130, 039130, 121130, 105120, 169120, 170120, 034130, 099130, 003130, 071130 & 076130, Product No. 037-28F, Lot #140120, 143120, 106120, 119120, 165120, 085130, 161120, 116130, 129130, 045140, 120140 & 128140, Product No. 037-33, Lot #094120, 049120, 074120, 067120, 113120, 123120, 121120, 157120, 172120, 177120, 015130, 032130, 036130, 040130, 089130, 101130, 102130 & 117130, Product No. 037-35, Lot #002220, 004220, 006220, 001220, 065120, 005220 & 007220, Product No. 037-39, Lot #008320, 004320, 010320, 005320, 009320, 016320 & 002330, Product No. 037-39C, Lot # 006320 & 007320, Product No. 037-70, Lot #005220 & 007220, Product No. 041-28, Lot #006123, 007123, 016123, 017123, 018123, 035123, 034123, 027123, 039123, 040123, 028123, 026123, 046123, 047123, 045123, 048123, 053123, 062123, 063123, 064123, 069123, 080123, 070123, 056123, 071123, 072123, 081123, 057123, 075123, 076123, 074123, 058123, 083123, 088123, 089123, 090123, 003133, 084123, 004133, 006133, 011133, 012133, 013133, 023133, 021133, 025133, 026133, 027133, 031133, 032133, 037133, 038133, 039133, 042133, 044133, 043133, 045133, 051133, 050133, 058133, 059133, 062133, 060133, 066133, 064133, 065133 & 061133, Product No. 041-28C, Lot #008123, 015123, 022123, 042123, 086123, 007133, 033123, 022133, 040133, 067133, 066123, 028133 & 030133, Product No. 041-33, Lot #006123, 021123, 029123, 036123, 048123, 053123, 064123, 058123, 085123, 091123, 025133, 042133, 051133, 052133, 062133, 058133 & 041133, Product No. 041-35, Lot #001223, 002223, 001233, 003223 & 003233, Product No. 044-28, Lot #038124, 008124, 011124, 014124, 012124, 013124, 032124, 037124, 033124, 064124, 066124, 065124, 073124, 061124, 074124, 076124, 039124, 060124, 083124, 081124, 077124, 084124, 006134, 011134, 012134, 013134, 017134, 016134, 023134, 024134, 029134, 030134, 032134, 033134, 036134, 045134, 037134, 051134, 057134 & 052134, Product No. 044-28C, Lot #009124, 020124, 078124, 008134, 048124, 026134, 035124, 062124, 018134 & 055134, Product No. 044-28F, Lot #040124, 063124, 067124, 049124, 079124, 003134, 050134, 004144, 010144, 017144, 022144 & 030144, Product No. 044-33, Lot #045124, 018124, 019124, 033124, 034124, 064124, 050124, 077124, 060124, 084124, 007134, 004134, 033134, 037134, 045134, 052134 & 057134, Product No. 044-35, Lot #001224, 003224, 004224, 005224, 006224, 001234, 002234 & 003234, Product No. 044-70, Lot #001234.
Products Sold
Product No. 403728, Lot #104120, 114120, 132120, 120120, 155120, 158120, 144120, 164120, 008130, 013130, 023130, 035130, 038130, 049130, 060130, 072130, 054130, 100130, 115130, 128130, 142130 & 020140; Product No. 404128, Lot #065123, 068123, 051123, 077123, 060123, 087123, 005133, 082123, 035133, 029133, 048133, 053133, 056133, 063133, 068133, 076133, 083133, 055123 & 052123; Product No. 404428, Lot #041124, 080124, 002134, 085124, 009134, 019134, 025134, 035134, 049134, 039134, 044134, 056134, 061134, 060134, 003144 & 046124; Product No. 037-28, Lot #083120, 069120, 081120, 068120, 050120, 024120, 023120, 030120, 040120, 042120, 031120, 041120, 051120, 049120, 053120, 052120, 064120, 070120, 071120, 075120, 072120, 078120, 077120, 080120, 034123, 129120, 082120, 084120, 079120, 067120, 076120, 092120, 090120, 094120, 096120, 085120, 091120, 131120, 130120, 095120, 133120, 138120, 097120, 145120, 098120, 134120, 139120, 147120, 146120, 141120, 151120, 152120, 153120, 157120, 159120, 160120, 173120, 166120, 167120, 172120, 174120, 004130, 002130, 177120, 007130, 006130, 005130, 015130, 019130, 010130, 011130, 017130, 016130, 020130, 018130, 021130, 033130, 022130, 024130, 025130, 026130, 036130, 028130, 032130, 027130, 040130, 051130, 041130, 042130, 050130, 052130, 062130, 063130, 064130, 066130, 067130, 077130, 073130, 074130, 075130, 078130, 089130, 118130, 090130, 091130, 119130, 092130, 102130, 103130, 104130, 113130, 110130, 111130, 112130, 114130 & 117130; Product No. 037-28C, Lot #073120, 103120, 093120, 142120, 162120, 012130, 055120, 061130, 039130, 121130, 105120, 169120, 170120, 034130, 099130, 003130, 071130 & 076130; Product No. 037-28F, Lot #140120, 143120, 106120, 119120, 165120, 085130, 161120, 116130, 129130, 045140, 120140 & 128140; Product No. 037-33, Lot #094120, 049120, 074120, 067120, 113120, 123120, 121120, 157120, 172120, 177120, 015130, 032130, 036130, 040130, 089130, 101130, 102130 & 117130; Product No. 037-35, Lot #002220, 004220, 006220, 001220, 065120, 005220 & 007220; Product No. 037-39, Lot #008320, 004320, 010320, 005320, 009320, 016320 & 002330; Product No. 037-39C, Lot # 006320 & 007320; Product No. 037-70, Lot #005220 & 007220; Product No. 041-28, Lot #006123, 007123, 016123, 017123, 018123, 035123, 034123, 027123, 039123, 040123, 028123, 026123, 046123, 047123, 045123, 048123, 053123, 062123, 063123, 064123, 069123, 080123, 070123, 056123, 071123, 072123, 081123, 057123, 075123, 076123, 074123, 058123, 083123, 088123, 089123, 090123, 003133, 084123, 004133, 006133, 011133, 012133, 013133, 023133, 021133, 025133, 026133, 027133, 031133, 032133, 037133, 038133, 039133, 042133, 044133, 043133, 045133, 051133, 050133, 058133, 059133, 062133, 060133, 066133, 064133, 065133 & 061133; Product No. 041-28C, Lot #008123, 015123, 022123, 042123, 086123, 007133, 033123, 022133, 040133, 067133, 066123, 028133 & 030133; Product No. 041-33, Lot #006123, 021123, 029123, 036123, 048123, 053123, 064123, 058123, 085123, 091123, 025133, 042133, 051133, 052133, 062133, 058133 & 041133; Product No. 041-35, Lot #001223, 002223, 001233, 003223 & 003233; Product No. 044-28, Lot #038124, 008124, 011124, 014124, 012124, 013124, 032124, 037124, 033124, 064124, 066124, 065124, 073124, 061124, 074124, 076124, 039124, 060124, 083124, 081124, 077124, 084124, 006134, 011134, 012134, 013134, 017134, 016134, 023134, 024134, 029134, 030134, 032134, 033134, 036134, 045134, 037134, 051134, 057134 & 052134; Product No. 044-28C, Lot #009124, 020124, 078124, 008134, 048124, 026134, 035124, 062124, 018134 & 055134; Product No. 044-28F, Lot #040124, 063124, 067124, 049124, 079124, 003134, 050134, 004144, 010144, 017144, 022144 & 030144; Product No. 044-33, Lot #045124, 018124, 019124, 033124, 034124, 064124, 050124, 077124, 060124, 084124, 007134, 004134, 033134, 037134, 045134, 052134 & 057134; Product No. 044-35, Lot #001224, 003224, 004224, 005224, 006224, 001234, 002234 & 003234; Product No. 044-70, Lot #001234.
Teleflex Medical is recalling Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adap due to Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility of the adaptor.. 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
Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility of the adaptor.
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