Medline urology and gynaecology kits contain catheters failing specifications
Medline procedure kits including robotic cystectomy, D&C and lithotomy packs are being recalled because sample catheters did not meet performance specifications. 32,438 units 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 medical procedure kits labeled as Kit Uro Robot Cystectomy, D and C Pack, MAD D & C, VPH Lithotomy Minor, TRMC-Peri GYN Pack and Rich Minor Lithotomy, among the products listed in the recall documents. The action covers 32,438 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: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TRMC- PERI GYN PACK, RICH MINOR LITHOTOMY, etc. (see recall documents for a full list of products)
- Manufacturer
- Medline Industries, LP
- Affected units
- 32,438
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)
- Medline Kit Number/SKU DYNJ83242B: UDI/DI 10198459157028 (each)
- 40198459157029 (case)
- Lot Number 25HBR321
- Lot Number 25GBD202
- Lot Number 25FBK813
- Lot Number 25EBG207
- Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each)
- 40195327193455 (case)
- Lot Number 23FBK499
- Lot Number 23EBV071
- Lot Number 22KBK089
- Lot Number 22IBV707
- Lot Number 22HBC310
- Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each)
- 40195327451654 (case)
- Lot Number 26DMG168
- Lot Number 26CMD637
- Lot Number 25KMC849
- Lot Number 25JMA672
- Lot Number 25DMC189
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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