{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Athlone", "state": "", "country": "Ireland", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "79579", "recalling_firm": "Teleflex Medical Europe Ltd", "address_1": "Ida Business Park", "address_2": "", "postal_code": "N/A", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Telephone", "distribution_pattern": "US Nationwide Distribution", "recall_number": "Z-1367-2018", "product_description": "Latex Rebreathing Bags: Product Code\tEquivalent Code (a) 151174050\t151174 (b) 153000005\t153000005 (c) 153000010\t153000010 (d) 153000020\t153000020 (e) 153000030\t153000030 (f) 153000050\t153000050 (g) 210700050\t2107050 (h) 210700102\t2107102 (I) 210700202\t2107202 (j) 210700302\t2107302 (k) 210700402\t2107402 (l) 210700502\t2107502 (m) 210700602 2107602 Product Usage: Rebreathing Bag is indicated for manual patient ventilation or in connection with anaesthesia apparatus and/or patient ventilators.", "product_quantity": "107962 units", "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.", "recall_initiation_date": "20180315", "center_classification_date": "20180705", "termination_date": "20201005", "report_date": "20180418", "code_info": "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 8563059 8774178 9038377 9038378 9038379 9038380 9038381 9219953 9249360 9498125 9608313 9796523 9933121 9933123 (e) 153000030 153000030 Batch Numbers: 10026945 10026946 10056453 10142568 10209248 10400856 10747908 10825068 10907835 11003798 11078592 11078593 11450496 11458647 11620321 11704031 12079373 12527197 7176396 7668817 7889068 8055293 8080271 8217004 8384637 8465218 8752941 8774180 8939533 8972831 9038382 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10509800 10608967 10636350 10636351 10636352 10747919 10747920 10747921 10747922 10747923 10772449 10846473 10983309 10983310 10983311 10983312 10983313 11077681 11078602 11078603 11078604 11105582 11188562 11218440 11218441 11218442 11218443 11226806 11258124 11281307 11301925 12827729 12827730 12827731 13064614 13226011 13226035 13229543 7702963 7702964 7702965 7889117 7976017 8013070 8013194 8080274 8217006 8293611 8465223 8563062 8665961 8725828 8774184 8972834 9038457 9038458 9038459 9038460 9038461 9038462 9038463 9038464 9038465 9038466 9038467 9038468 9038469 9038470 9038471 9038472 9038473 9038474 9038475 9038476 9038477 9038478 9038479 9038480 9038481 9038482 9038483 9038484 9038485 9038486 9038487 9038488 9038489 9038490 9054954 9100523 9176068 9176069 9176070 9284578 9284579 9387493 9416792 9495392 9701523 9727281 9727282 9727283 9754645 9796527 9813695 9813696 9813697 9904762 9933129 9933130 9933131 13294050 (added 27 JUN 18) 13294051 (added 27 JUN 18) (k) 210700402 2107402 Batch Numbers: 10236106 10263082 10263083 10286588 10286589 10346588 10425384 10480127 10508213 10508214 10508215 10508216 10508217 10521583 10536133 10614864 10636354 10636355 10747924 10747925 10747926 10747927 10959881 10983314 10983315 11003800 11078605 11078606 11105583 11188563 11218444 11281308 11301927 11301928 11390994 11390995 11390996 12827764 12827765 12827766 13064650 13064651 13154082 13154083 13247605 7446834 7702967 7702968 7889119 7976018 8021785 8080275 8293612 8384641 8462768 8462769 8462770 8462771 8462772 8725829 8774185 9038491 9038492 9038493 9038494 9038495 9038496 9038497 9038498 9038499 9038500 9038501 9038502 9038503 9038504 9038505 9038506 9038507 9038508 9038509 13294084 (added 27 JUN 18) 13294085 (added 27 JUN 18) (l) 210700502 2107502 Batch Numbers: 10056455 10147570 10147571 10263084 10286590 10317922 10317923 10412854 10636358 10747930 10747931 10747932 10825069 10846475 10846476 10983316 10983317 10983318 10983319 10983320 10983321 10983322 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