X-Flow Prostatectomy Catheter Recalled for Possible Sterility Defect
Coloplast is recalling 36,369 X-Flow prostatectomy catheters due to a possible sterility issue detected at its manufacturing facility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a possible sterility defect on a medical device used internally in urological procedures, with no reported illnesses or injuries. This meets the High severity criterion as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Coloplast Manufacturing US, LLC is recalling 36,369 X-Flow prostatectomy catheters across multiple Device Reference Numbers due to a possible sterility issue discovered at the manufacturer's facility.
The sterility defect could affect the devices' ability to maintain a sterile field. These catheters are intended for use in urological procedures where sterility is critical to prevent infection.
The affected devices were distributed nationwide in the US and in Canada. Device Reference Numbers and lot numbers for the recall are available from the FDA and the manufacturer.
Consumers and healthcare providers who have received these devices should verify their product against the recall list using the Device Reference Number and lot number. Contact Coloplast Manufacturing for instructions on how to proceed with replacement or return.
The recalled product
- Product
- X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.
- Manufacturer
- Coloplast Manufacturing US, LLC
- Affected units
- 36,369
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)
- Device Reference Number AB6022
- GTIN 3600040143377
- Lot Numbers: 8884608
- 9132241
- 9213522
- 9396680
- 9404775
- 9495823
- 9495824
- Device Reference Number AB6024
- GTIN 3600040143506
- Lot Numbers: 8156931
- 8865281
- 9102857
- 9453594
- Device Reference Number AB6118
- GTIN 3600040143636
- Lot Numbers: 8691180
- Device Reference Number AB6120
- GTIN 3600040143728
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Coloplast Manufacturing US, LLC 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.
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