Recall Z-1974-2019 ยท KNX Collector, Urine, (And Accessories) For Indwelling Catheter
Teleflex Medical
RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
| Date | Jan 14, 2019 |
| Status | Terminated |
| Reason | The device labels are not UDI compliant. The missing UDI compliance information on the labelling is not likely to affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling. |
| Root cause | Labeling Change Control |
| Action | The firm, Teleflex, sent an "Urgent Medical Device Recall" letter dated 01/14/2019 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue the use of the products and quarantine them, and complete the enclosed Recall Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com or hand it to your sales representative. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instru |
| Quantity | 105426 US eaches |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.