Medline urethroplasty kits contain catheters failing performance specifications
Medline urology urethroplasty procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 91 units are affected.
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: FDA Class II recall where a catheter connector can detach in use and dimensions fall out of specification, a risk of harm with no injuries reported.
Plain-English summary
Medline Industries, LP is recalling urethroplasty procedure kits, covering the Kit Urology Urethroplasty (DYKMBNDL117C) and the Urethroplasty kits (DYNJ908978, DYNJ908978F). The action covers 91 units.
During an internal review, Medline identified that representative samples did not meet applicable performance specifications. According to the firm, the identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. The FDA classified the action as Class II.
Distribution was worldwide, including nationwide in the United States. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the kit numbers, UDI codes and lot numbers in the recall notice, quarantine it, and follow the instructions issued by Medline.
The recalled product
- Product
- MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117C; 2) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978; 3) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978F.
- Manufacturer
- Medline Industries, LP
- Affected units
- 91
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 (14)
- Medline Kit Number/SKU DYKMBNDL117C: UDI/DI 10195327371104 (each)
- 40195327371105 (case)
- Lot Number 23DLA834
- Medline Kit Number/SKU DYNJ908978: UDI/DI 10195327231132 (each)
- 40195327231133 (case)
- Lot Number 23BMC463
- Lot Number 23AMA685
- Lot Number 23AMB905
- Lot Number 22LMG466
- Lot Number 22LMB983
- Medline Kit Number/SKU DYNJ908978F: UDI/DI 10198459228803 (each)
- 40198459228804 (case)
- Lot Number 25JBD225
- Lot Number 25HBW236.
Distribution
Part of a larger recall action
This product is one of 30 recalled by Medline Industries, LP 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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