Recall Z-1241-2014— Convatec Inc.
Class II · Terminated
Class II FDA medical device recall by Convatec Inc., initiated 2014-02-07, terminated 2014-12-18. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material..
- Recalling firm
- Convatec Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-02-07
- Terminated
- 2014-12-18
- Firm location
- Skillman, NJ, United States
Product description
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.
Reason for recall
The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
Data sourced from openFDA. This site is unofficial and independent of the FDA.