—#170405

Product

RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device

FDA product code: KNX — Collector, Urine, (And Accessories) For Indwelling Catheter
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: GTIN: 14026704645715 Lot/Batch Numbers: 20161005 20161120 20161125 20170105 20170210 20170401 20170402 20170501 20170801 20170901 20170902 20170903 20170904 20171101 20170701

Why it was recalled

The device labels are not UDI compliant. The missing UDI compliance information on the labelling would not affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 3015 Carrington Mill Blvd, Morrisville, North Carolina 27560-5437

Distribution

Distribution pattern: Worldwide Distribution: US (nationwide) and countries of: Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador.

Timeline

Recall initiated: 2019-01-14
Terminated: 2022-12-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #170405. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.