SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: 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.
Recall
- Recall Number
- Z-1238-2014
- Event Number
- 67588
- Firm
- Convatec Inc.
- FEI Number
- 3011987967
- Product Code
- KOD
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- February 7, 2014
- Posted
- March 20, 2014
- Terminated
- December 18, 2014
- Address
- 200 Headquarters Park Dr, Skillman, NJ, 08558-2600
Description
SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: 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.
The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
Convatec sent Urgent: Voluntary Medical Device Recall letters dated 2/7/2014 via UPS and email. Foreign customers were provided the notice via DHL. The letter identified the affected product, problem and actions to be taken. Customers are asked to perform a count of recalled product in inventory. All consignees should be contacted and be instructed to return product based on their procedures. Customers were instructed to complete and return the enclosed respoonse form.
Worldwide Distribution and in the state of TX
5,540 catheters