Aquapak Adaptor — Class II medical device recall Z-0504-2015
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-0504-2015 |
|---|---|
| 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 | 02A1202382, 02A1202383, 02A1202384, 02A1300194, 02A1300457, 02A1300458, 02B1201069, 02B120342, 02B1300717, 02B1300718, 02B1301203, 02D1200247, 02D1200248, 02D1200249, 02D1201944, 02D1202233, 02D1202234, 02D1202236, 02D1202258, 02D1202259, 02D1202260, 02D1202261, 02D1202274, 02D1202733, 02D1202734, 02D1202735, 02D1300864, 02D1301191, 02D1301192, 02D1301655, 02D1302730, 02D1302731, 02E1200717, 02E1200718, 02E1200719, 02E1200720, 02E1201279, 02E1201281, 02E1201282, 02E1201563 and 44 more |
Product
Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB, INTL, Product No. 403133; Aqaupak Nebulizer Adaptor 028, Sterile, Shelfpak, Product No. 031-28 & 031-28F, Aqaupak Nebulizer Adaptor 033, Sterile, Shelfpak, Product No. 031-33; Aqaupak Nebulizer Adaptor 033, Sterile, Japanese, Product No. 031-33J. 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-0504-2015. 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.