RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
Recall
- Recall Number
- Z-1974-2019
- Event Number
- 81954
- Firm
- Teleflex Medical
- FEI Number
- 3005747797
- Product Code
- KNX
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- January 14, 2019
- Terminated
- December 13, 2022
- Address
- 3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437
Description
RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
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.
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 [email protected] 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.
Worldwide Distribution: US (nationwide) and countries of: Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador.
105426 US eaches