Teleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
Teleflex Medical is recalling RuSCH One piece Male External Regular Catheters because the labels incorrectly state the devices are sterile, though they are not required to be.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a minor labeling error regarding sterility status for a device not required to be sterile.
Plain-English summary
Teleflex Medical is recalling 39,456 units of the RuSCH One piece Male External Regular Catheter W/O Tape (REF A1500). The recall is due to a labeling error where the device label incorrectly states that the device is sterile. The 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. The affected units were distributed in Maine, North Carolina, Washington, Missouri, New Jersey, Florida, California, Texas, Ohio, Illinois, Massachusetts, Georgia, and Canada.
Consumers and healthcare facilities should stop using the affected devices and contact Teleflex Medical for further instructions. The specific lot numbers affected are listed in the agency's recall record Z-0796-2020.
The recalled product
- Product
- Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 39,456
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 24026704549836 Lot Numbers: 74A1800914
- 74A1801938
- 74A1802088
- 74B1800292
- 74B1800362
- 74B1801603
- 74C1800428
- 74C1801090
- 74C1801172
- 74C1802127
- 74E1800684
- 74E1802780
- 74F1800358
- 74F1801409
- 74F1801915
- 74G1800046
- 74G1800893
- 74G1801165
- 74H1700889
- 74H1701630
Distribution
Part of a larger recall action
This product is one of 2 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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