Reported Apr 18, 2018 · Terminated
Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into…
Teleflex Medical Europe Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teleflex Medical Europe Ltd · Ida Business Park · Athlone · N/A
Is this the product you have?
- Rectal Catheters; Product Code Equivalent
- Code 580114 580114 Product UsageRectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled
- Lot codes and dates
- Batch Numbers
13DE1713EE2213FE2413FE2613GE2813GE2913GE3113KE4713LE4914AE0314AE0414FE2514GE2714HE3214HE3314HE3514IE3714IE3814LE4915AE0515BE0815CE1315DE1515DE1615DE1715DE1815FE2315FE2515FE2615GE2715GE2815GE2915GE3015HE32
- Batch Numbers
- Amount recalled
- 6340 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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