Convatec Inc. recalls SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous Coated Foley Catheters The stan

Recalled March 26, 2014 · FDA recall Z-1241-2014 · Convatec

Hazard

The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material. · FDA Class II

Units

4,760 catheters

Sold at

Worldwide Distribution and in the state of TX

Description

The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.

Product

SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex 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.

Manufacturer(s)

Convatec Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →