Teleflex Medical recalls Simplastic suprapubic puncture instruments with latex that may cause allergic reactions. Affected products include specific model codes and 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 Simplastic suprapubic puncture instruments that contain latex but lack a warning label about potential allergic reactions. This recall affects medical devices used for emergency bladder drainage in hospitals and clinics. The hazard is a risk of allergic reactions in sensitive individuals, which could lead to serious health issues if they have latex allergies.
These medical instruments contain natural rubber latex, which can cause allergic reactions in people sensitive to latex. The absence of a required allergy warning label means users might not be aware of this risk, especially in medical settings where latex exposure is common.
Healthcare professionals and patients who use these instruments for emergency bladder drainage are most at risk. Individuals with known latex allergies should avoid using these products.
Check the product packaging for the model codes: (a) 650704100/551310, (b) 650704120/551312, or (c) 650704160/551316. Also look for batch numbers listed in the recall notice.
Look for the model codes and batch numbers listed in the recall notice to confirm if your instrument is affected.
The recall is because these instruments contain latex but lack a required warning label about potential allergic reactions.
No, but individuals with latex allergies should avoid using them. Healthcare providers should check for affected instruments before use.
Check the product packaging for the model codes (a) 650704100/551310, (b) 650704120/551312, or (c) 650704160/551316 and the associated batch numbers.
We’ve drafted a message you can send Teleflex Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1369-2018 — Teleflex Medical Teleflex Medical Hello, I own a Teleflex Medical that is covered by recall Z-1369-2018 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.
