FDA recall Z-1367-2018

Teleflex Medical Europe Ltd · Class II · device

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

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

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