Latex Rebreathing Bags
Medical device recall Z-1367-2018. Published in FDA’s Enforcement Report on Apr 18, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 18, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 107962 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
107962 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,995 characters
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 9038384 9097574 9249361 9473122 9595217 9595218 9700495 9700496 9700497 9796524 12790887 (added 27 JUN 18) (f) 153000050 153000050 Batch Numbers: 10236105 10508208 10614862 11078594 11078595 11562396 8021784 8384638 8725825 9038386 9444407 (g) 210700050 2107050 Batch Numbers: 10216572 10263076 10521582 10772448 10846470 11301920 11534384 11644615 11769841 12055032 12827654 13064537 9140498 9176058 9176059 9238630 9656895 (h) 210700102 2107102 Batch Numbers: 10026947 10026948 10147559 10147560 10147561 10263077 10286580 10509798 10565412 10565413 10608966 10636346 10636347 10664670 10703604 10747910 10747911 10747912 10747913 10803495 10983299 10983300 10983301 10983302 11078596…
FDA’s list runs to 7,021 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide Distribution
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 15, 2018.
- FDA classified it on Jul 5, 2018.
- FDA’s Enforcement Report published it on Apr 18, 2018.
- FDA terminated it on Oct 5, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Teleflex Medical Europe Ltd, of Athlone, Ireland.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Telephone.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 7,021 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.