Recall Z-1974-2019
Teleflex Medical · initiated January 14, 2019
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
Codes / lots: GTIN: 14026704645708 Lot/Batch Numbers: 20161005 20161120 20161125 20170105 20170210 20170301 20170401 20170402 20170501 20170601 20170801 20170902 20170904 20171001 20171101 20171201 20180101 20170802 20170701
Reason for recall
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.
FDA-determined cause: Labeling Change Control
Action taken
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 instructions for the return of products. Distributors were directed to notify their consignees. The recalling firm is seeking the return of the affected products. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.
Details
- Recall number
- Z-1974-2019
- Initiated
- January 14, 2019
- Terminated
- December 13, 2022
- Product code
- KNX – Collector, Urine, (And Accessories) For Indwelling Catheter
- Quantity
- 105426 US eaches
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador.
- Recalling firm
- Teleflex Medical, Morrisville, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1975-2019 Class III | RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection deviceThe device labels are not UDI compliant. The missing UDI compliance information on the labelling would not… | 01/14/2019Terminated |