Aquapak 340 SW — Class II medical device recall Z-2003-2014
Terminated recall by Teleflex Medical, reported 2014-07-16, distributed nationwide. The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect pack
| Recall number | Z-2003-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Durham, NC, United States |
| Recall initiated | 2014-06-05 |
| Classified | 2014-07-07 |
| Reported by FDA | 2014-07-16 |
| Terminated | 2015-07-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, CN, DE, FR, GB, IN, MX, MY, PH, SG, TH |
| Quantity | 7,758,650 units |
| Reason classes | packaging |
| Lot numbers | 082127, 085127, 088127, 092127, 094127, 097127, 100127, 102127, 104127, 106127, 108127, 137127, 141127, 145127, 148127, 154127, 156127, 159127, 161127, 163127, 194127, 198127, 200127, 204127, 207127, 209127, 223127, 224127, 226127, 228127, 230127, 232127, 239127, 241127, 243127, 245127, 246127, 248127, 250127, 252127 and 58 more |
Product
Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
Reason for recall
The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity.
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-2003-2014. 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.