RUSCH recallZ-1974-2019 · Teleflex Medical · initiated Jan 14, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Teleflex Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Labeling Change Control
What the company is doing
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.
Recall details
- Recall number
- Z-1974-2019
- Status
- Terminated
- Initiated by the company
- Jan 14, 2019
- Recalling firm
- Teleflex Medical
- Quantity
- 105426 US eaches
- Product code
- KNX
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador.
Product description
RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
Code information (models, lots, serial numbers)
GTIN: 14026704645708 Lot/Batch Numbers: 20161005 20161120 20161125 20170105 20170210 20170301 20170401 20170402 20170501 20170601 20170801 20170902 20170904 20171001 20171101 20171201 20180101 20170802 20170701
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- RUSCH IPN054581Teleflex Incorporated · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 81954).
- Z-1975-2019 · TerminatedRUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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