AQUAPAK SW/EAU STERILE — Class II medical device recall Z-1099-2015
Terminated recall by Teleflex Medical, reported 2015-02-18, distributed nationwide. The packages may contain foreign material (black particles).
| Recall number | Z-1099-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Research Triangle Park, NC, United States |
| Recall initiated | 2015-01-14 |
| Classified | 2015-02-11 |
| Reported by FDA | 2015-02-18 |
| Terminated | 2017-12-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BH, BM, BR, CA, CN, DE, EC, GB, HK, ID, JO, JP, KR, MX, MY, NZ, PH, SA, SG, TH, TW, UY |
| Quantity | 15,779,607 units |
| Reason classes | foreign material |
| Lot numbers | 021147, 067147, 099147, 124147, 127147, 144137, 173147, 187137, 193137, 210137, 230147, 249137, 280147, 295137, 296137, 307147, 324137, 346147, 354147, 355147, 357147, 410147, 411137, 414137, 415147, 451137, 473137, 504137, 536137, 553137, 592137, 612137, 615137 |
Product
AQUAPAK SW/EAU STERILE, 340 ML W/ADAPTOR Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
Reason for recall
The packages may contain foreign material (black particles).
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-1099-2015. 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.