Teleflex Medical Europe recalls rectal balloon catheters with latex that may cause allergic reactions. Affected units have specific batch numbers. Consumers should check packaging for the allergy warning.
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.
Teleflex Medical is recalling rectal balloon catheters that contain latex but lack a warning about potential allergic reactions. This could cause serious allergic reactions in sensitive individuals, especially during medical use.
The catheters contain natural rubber latex which can cause allergic reactions in sensitive individuals. Without a clear warning label, people with latex allergies might not know to avoid these products during medical procedures.
Patients and healthcare providers using rectal catheters for medical procedures. Those with latex allergies are at higher risk of severe reactions.
Check the product packaging for batch numbers: 13DE17, 13EE22, 13FE24, 13FE26, 13GE28, 13GE29, 13GE31, 13KE47, 13LE49, 14AE03, 14AE04, 14FE25, 14GE27, 14HE32, 14HE33, 14HE35, 14IE37, 14IE38, 14LE49, 15AE05, 15BE08, 15CE13, 15DE15, 15DE16, 15DE17, 15DE18, 15FE23, 15FE25, 15FE26, 15GE27, 15GE28, 15GE29, 15GE30, 15HE32.
Look for batch numbers listed in the recall: 13DE17, 13EE22, 13FE24, 13FE26, 13GE28, 13GE29, 13GE31, 13KE47, 13LE49, 14AE03, 14AE04, 14FE25, 14GE27, 14HE32, 14HE33, 14HE35, 14IE37, 14IE38, 14LE49, 15AE05, 15BE08, 15CE13, 15DE15, 15DE16, 15DE17, 15DE18, 15FE23, 15FE25, 15FE26, 15GE27, 15GE28, 15GE29, 15GE30, 15HE32.
The recall does not require immediate stop use; however, individuals with latex allergies should avoid these products.
Check the product packaging for batch numbers listed in the recall. If you have the affected batch numbers, contact Teleflex Medical for guidance.
The hazard is a potential allergic reaction, which could be serious for individuals with latex allergies, but the recall does not specify a risk of injury in normal use.
We’ve drafted a message you can send Teleflex Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1368-2018 — Teleflex Medical Teleflex Medical Hello, I own a Teleflex Medical that is covered by recall Z-1368-2018 from Teleflex Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
