FDA Device recall Z-1367-2018
Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010 153000010 (d) 153000020 153…
- FDA Device
- Class II
- terminated
- Published 2018-04-18
On 2018-04-18 the FDA classified a Class II recall of Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010 153000010 (d) 153000020 153… by Teleflex Medical Europe, citing 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 Al….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1367-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-15 |
| Published | 2018-04-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Teleflex Medical Europe |
| Distribution | US |
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
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.
Identifiers
| code_info | Product Code Equivalent Code (a) 151174050 151174 Batch Numbers: 11218023 11218024 7702798 8084124 8322324 8384…Product Code Equivalent Code (a) 151174050 151174 Batch Numbers: 11218023 11218024 7702798 8084124 8322324 8384447 (b) 153000005 153000005 Batch Numbers: 10263072 10565411 10636343 10742167 11078589 11105577 11188556 11301914 11390984 11644614 7889062 8021782 8055291 8080268 8217002 8774177 8972828 9038367 9038368 9038370 9123586 9284572 9387490 9416790 9515204 (c) 153000010 153000010 Batch Numbers: 10263073 10425381 10425382 10747907 10825066 11078590 11301915 11534382 11760316 11769838 11857438 8021783 8055292 8080269 8217003 8774176 8972829 9038372 9038373 9038374 9038375 9038376 9310179 9416791 9507992 9536655 9579791 9700489 9700490 9700491 9700492 9706325 9796522 9813690 (d) 153000020 153000020 Batch Numbers: 10147558 10346587 10379115 10690085 10825067 10846469 11078591 11105579 11188558 11390987 11534383 11769839 11857439 11873098 7889065 7889066 7889067 8293609 8384636 856305 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1367-2018%22
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