# FDA recall Z-1367-2018

> **Teleflex Medical Europe Ltd** · Class II · device recall initiated 2018-03-15.

## 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.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-1367-2018
- **Recalling firm:** Teleflex Medical Europe Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-15
- **Report date:** 2018-04-18
- **Termination date:** 2020-10-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Athlone, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1367-2018

## Citation

> AI Analytics. FDA recall Z-1367-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-1367-2018. Source: US FDA. Licensed CC0.

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