Aqauapak 728 SW recall: Sterility Concern
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…
Why was Aqauapak 728 SW recalled?
Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility of the adaptor.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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…
- Recalling firm
- Teleflex Medical
- Quantity
- 3,193,548 ea.
- Distribution
- Worldwide Distribution-US (nationwide) including Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY, and the countries of United Arab Emirates, Australia, Belgium, Brazil, Canada, Chile, China, France, Great Britain, Japan, India, Indonesia, Israel, South Korea, Mexico, Philippines, Saudi Arabia, Singapore, Taiwan, Thailand, Uruguay, and Zambia.
- Recall date
- December 10, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)