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U.S. Department of Health and Human Services

Class 3 Device Recall RUSCH CARE Premium Drain bag

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  Class 3 Device Recall RUSCH CARE Premium Drain bag see related information
Date Initiated by Firm January 14, 2019
Create Date July 15, 2019
Recall Status1 Terminated 3 on December 13, 2022
Recall Number Z-1974-2019
Recall Event ID 81954
Product Classification Collector, urine, (and accessories) for indwelling catheter - Product Code KNX
Product RUSCH CARE Premium Drain bag, 2000mlm REF 390000

urine collection device
Code Information GTIN: 14026704645708  Lot/Batch Numbers: 20161005 20161120 20161125 20170105 20170210 20170301 20170401 20170402 20170501 20170601  20170801 20170902 20170904 20171001  20171101 20171201 20180101 20170802 20170701
Recalling Firm/
Manufacturer		 Teleflex Medical
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 105426 US eaches
Distribution Worldwide Distribution: US (nationwide) and countries of: Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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