Recall Z-1158-2013 ยท KNX Collector, Urine, (And Accessories) For Indwelling Catheter
Teleflex Medical
Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile urine collection device that collects urine by mechanical means when attached to an indwelling Foley or suprapubic catheter.
| Date | Apr 22, 2013 (initiated Mar 28, 2013) |
| Status | Terminated |
| Reason | Sterile packaging may be compromised. |
| Root cause | Nonconforming Material/Component |
| Action | Teleflex Medical sent an Urgent Medical Device Recall Notification dated March 28, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed if you have any of the affected stock, immediately discontinue use and quarantine any products with the catalog numbers listed. If you and your customers have no affected stock please complete the enclosed Recall Acknowledgement Form and fax it to 1 (866) 804-9881 Attn: Customer Service. This will allow us to document your receipt of this letter. To return |
| Quantity | 190,103 |
| Distribution | Worldwide Distribution - USA and the countries of Singapore, Canada, New Zealand, Germany, Ireland, Japan and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.