Reported Mar 26, 2014 · Terminated
SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous Coated Foley Catheters The…
Convatec Inc.
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: Convatec Inc. · 200 Headquarters Park Dr · Skillman, NJ · 08558-2600
Is this the product you have?
- SLC 3-way standard Lubricious
- Coated 20Ch/Fr 30 mL/cc Product UsageLatex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes
- Lot codes and dates
- 540204R001
- Amount recalled
- 4,760 catheters
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
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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