Latex Rebreathing Bags: Product Code Equivalent Code — Class II medical device recall Z-1367-2018
Terminated recall by Teleflex Medical Europe Ltd, reported 2018-04-18, distributed nationwide. These products contain latex, but the following statement is not included on any level of product packaging: C
| Recall number | Z-1367-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical Europe Ltd, Athlone, Ireland |
| Recall initiated | 2018-03-15 |
| Classified | 2018-07-05 |
| Reported by FDA | 2018-04-18 |
| Terminated | 2020-10-05 |
| Distributed | Nationwide (US) |
| Quantity | 107,962 units |
| Lot numbers | 10026945, 10026946, 10026947, 10026948, 10026951, 10026952, 10056453, 10056455, 10142568, 10147558, 10147559, 10147560, 10147561, 10147563, 10147566, 10147570, 10147571, 10204662, 10209248, 10216572, 10236105, 10236106, 10263072, 10263073, 10263076, 10263077, 10263078, 10263079, 10263081, 10263082, 10263083, 10263084, 10286580, 10286584, 10286585, 10286586, 10286587, 10286588, 10286589, 10286590 and 460 more |
Product
Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010 153000010 (d) 153000020 153000020 (e) 153000030 153000030 (f) 153000050 153000050 (g) 210700050 2107050 (h) 210700102 2107102 (I) 210700202 2107202 (j) 210700302 2107302 (k) 210700402 2107402 (l) 210700502 2107502 (m) 210700602 2107602 Product Usage: Rebreathing Bag is indicated for manual patient ventilation or in connection with anaesthesia apparatus and/or patient ventilators.
Reason for recall
These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
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-1367-2018. 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.