Teleflex MEDICAL RuSCH One piece Male External Medium recall
Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M
Why was Teleflex MEDICAL RuSCH One piece Male External Medium recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M
- Recalling firm
- Teleflex Medical
- Quantity
- 13104 devices
- Distribution
- ME,NC, WA, MO, NJ, FL, CAL, TX, OH, IL, MA, GA, FL, GA, Canada
- Recall date
- January 22, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)