Teleflex Medical Recalls Latex Rebreathing Bags Due to Missing Allergen Warning
Teleflex Medical Europe Ltd is recalling 107,962 latex rebreathing bags because they lack the required warning that the product contains natural rubber latex, which may cause allergic reactions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves allergen mislabeling (missing latex warning) on a medical device, which fits the rubric criterion for 'Allergen mislabeling on common allergens' or 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Teleflex Medical Europe Ltd is recalling 107,962 units of Latex Rebreathing Bags distributed nationwide in the United States. The recall was initiated because the product packaging does not include the required statement: "Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."
The affected products are indicated for manual patient ventilation or in connection with anaesthesia apparatus and/or patient ventilators. The recall covers multiple product codes and batch numbers, including codes 151174050, 153000005, 153000010, 153000020, 153000030, 153000050, 210700050, 210700102, 210700202, 210700302, 210700402, 210700502, and 210700602.
Healthcare facilities and consumers should check their inventory for these specific product codes and batch numbers. If the product is found, it should be removed from use and returned to Teleflex Medical Europe Ltd or the distributor for credit or replacement, as directed by the company.
The recalled product
- 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) 21070
- Manufacturer
- Teleflex Medical Europe Ltd
- Affected units
- 107,962
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Teleflex Medical Europe Ltd under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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