CLASS II Device recall · Reported 10 Dec 2014 · FDA Enforcement Report
Aqauapak 728 SW W/028 Adaptor, Intl, Product No. recalled
Teleflex Medical is recalling Aqauapak 728 SW W/028 Adaptor, Intl, Product No. 403728, distributed nationwide in the US. The recall was initiated on 3 Sep 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0505-2015
- FDA event ID
- 69658
- Recalling firm
- Teleflex Medical, Durham, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Sep 2014
- FDA classified
- 4 Dec 2014
- Reported
- 10 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 3 Sep 2014 | Recall initiated by company | |
| 4 Dec 2014 | Classified by FDA | +92 days |
| 10 Dec 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility of the adaptor.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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; Aquapak 739 FNS, 760 ML W/028 Adaptor, Product No. 037-39; Aquapak 0.9% NACL, 760 ML W/Adaptor, Product No. 037-39C; Aquapak 770 HNS, 760 ML W/033 Adaptor, Product No. 037-70; Aquapak 1028 SW, 1070 ML W/028 Adaptor, Product No. 041-28; Aquapak SW/EAU Sterile, 1070 ML W/Adaptor, Product No. 041-28C; Aquapak 1033 SW, 1070 ML W/033 Adaptor; Product No. 041-33; Aquapak 1035 HNS, 1070 ML W/028 Adaptor, Product Code 041-35; Aquapak 428 SW, 440 ML W/028 Adaptor, Product No. 044-28; Aquapak SW/EAU Sterile, 440 MLW/Adaptor, Product No. 044-28C; Aquapak 428 SW, 440 ML W/028 Adaptor, French, Product No. 044-28F; Aquapak 433 SW, 440 ML W/033 Adaptor, Product No. 044-33; Aquapak 435 HNS, 440 ML W/028 Adaptor, Product No. 044-35; Aquapak 470 HNS, 440 ML W/033 Adaptor, Product No. 044-70. Used in anesthesiology.
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaine
Questions about this recall
Why was it recalled?
Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility of the adaptor.
Which lots 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.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 69658| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Aquapak Adaptor, 028 NEB, INTL, Product No. recalled by Teleflex Medical | Teleflex Medical | Sterility | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Teleflex Flex tube, Product #20011, sterile recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
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| Device | CLASS I | Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device) recalled | Teleflex Medical | Other | Nationwide |
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