Aqauapak 728 SW — Class II medical device recall Z-0505-2015
Terminated recall by Teleflex Medical, reported 2014-12-10, distributed nationwide. Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility of
| Recall number | Z-0505-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Durham, NC, United States |
| Recall initiated | 2014-09-03 |
| Classified | 2014-12-04 |
| Reported by FDA | 2014-12-10 |
| Terminated | 2017-08-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BR, CA, CL, CN, FR, GB, ID, IL, IN, JP, KR, MX, PH, SA, SG, TH, TW, UY |
| Quantity | 3,193,548 units |
| Reason classes | sterility |
| Lot numbers | 001220, 001223, 001224, 001233, 001234, 002130, 002134, 002220, 002223, 002234, 002330, 003130, 003133, 003134, 003144, 003223, 003224, 003233, 003234, 004130, 004133, 004134, 004144, 004220, 004224, 004320, 005130, 005133, 005220, 005224, 005320, 006123, 006130, 006133, 006134, 006220, 006224, 006320, 007123, 007130 and 352 more |
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; 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.
Reason for recall
Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility of the adaptor.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0505-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.