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U.S. Department of Health and Human Services

Class 3 Device Recall Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape

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  Class 3 Device Recall Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape see related information
Date Initiated by Firm February 27, 2019
Create Date January 10, 2020
Recall Status1 Terminated 3 on September 06, 2023
Recall Number Z-0797-2020
Recall Event ID 82307
Product Classification Sheath, corrugated rubber, for non-indwelling catheter, non-sterile - Product Code NNY
Product Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M
Code Information GTIN 24026704549843 Lot Numbers: 74A1800577, 74G1802121, 74A1801939, 74H1700894, 74B1800363, 74J1700864, 74B1801604, 74J1702489, 74B1802746, 74C1801178, 74K1702257, 74L1700074, 74C1801294 , 74L1701701, 74C1802132, 74M1700121, 74G1800047, 74M1701150, 74G1800891, 74M1701769, 74G1801166  
Recalling Firm/
Manufacturer		 Teleflex Medical
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
Manufacturer Reason
for Recall		 The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an alternative to incontinence pads. In normal use, the device is neither expected nor required to be sterile.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm initiated the recall by letter on 02/27/2019. The notice stated that the device label incorrectly identified the products as sterile. Although incorrectly labeled as sterile, there is no requirement for sterility for its use. The firm requested that the distributors notify their customers. The firm did not request the return of the units, only to attach the notice to any recalled product in stock.
Quantity in Commerce 13104 devices
Distribution ME,NC, WA, MO, NJ, FL, CAL, TX, OH, IL, MA, GA, FL, GA, Canada
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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