Teleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
Teleflex Medical is recalling RuSCH One piece Male External Medium 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 FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a labeling error regarding sterility status for a device not required to be sterile.
Plain-English summary
Teleflex Medical is recalling 13,104 units of the RuSCH One piece Male External Medium Catheter W/O Tape (REF A1500M). The recall was initiated because the device labels incorrectly state that the product is sterile. The RuSCH catheter is an externally applied male condom-type device designed for the management of male incontinence as an alternative to incontinence pads.
The recall covers specific lot numbers including 74A1800577, 74G1802121, and 74A1801939, among others. The affected devices were distributed in Maine, North Carolina, Washington, Missouri, New Jersey, Florida, California, Texas, Ohio, Illinois, Massachusetts, Georgia, and Canada.
In normal use, the device is neither expected nor required to be sterile. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers should check their devices against the listed lot numbers and contact Teleflex Medical for further instructions.
The recalled product
- Product
- Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 13,104
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 24026704549843 Lot Numbers: 74A1800577
- 74G1802121
- 74A1801939
- 74H1700894
- 74B1800363
- 74J1700864
- 74B1801604
- 74J1702489
- 74B1802746
- 74C1801178
- 74K1702257
- 74L1700074
- 74C1801294
- 74L1701701
- 74C1802132
- 74M1700121
- 74G1800047
- 74M1701150
- 74G1800891
- 74M1701769
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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