Z-1974-2019Class III

RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device

Name: Z-1974-2019 RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
Creator: Teleflex Medical
Published: 2019-01-14
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2019-01-14 / Terminated / root cause: labeling and UDI

FDA source

Teleflex Medical began a recall of RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device on 2019-01-14. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1974-2019
Classification: Class III
Status: Terminated
Initiated: 2019-01-14
Posted: 2019-07-15
Terminated: 2022-12-13
Recalling firm: Teleflex Medical
Product: RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
Product code: KNX Collector, Urine, (And Accessories) For Indwelling Catheter
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
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.
Quantity in commerce: 105426 US eaches
Distribution: Worldwide Distribution: US (nationwide) and countries of: Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador.
Product codes and 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1974-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1974-2019	Class III	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-15
Z-1975-2019	Class III	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-15

Product code KNX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)