Recall Z-1240-2014 ยท KOD Catheter, Urological
Convatec Inc.
'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL 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).
| Date | Mar 20, 2014 (initiated Feb 7, 2014) |
| Status | Terminated |
| Reason | The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 54,590 catheters |
| Distribution | Worldwide Distribution and in the state of TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.