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Terminated

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

FDA Recall Z-1975-2019 · Posted None

Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeKNX
Date Initiated2019-01-14
Date Terminated2022-12-13
Product Quantity76725 US eaches

Reason for Recall

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.

Firm 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 [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.

Root Cause

Labeling Change Control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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