Foley Urine Collection Kit recalled for non-sterile alcohol prep pads
LSL Healthcare is recalling its Foley Urine Collection Kit (Model 1555) because it contains Webcol Large Alcohol Prep Pads that are non-sterile. The kits were distributed nationwide in Maryland, Illinois, and Minnesota.
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 involving a contamination hazard (non-sterility) in a medical device kit used for invasive procedures. The source text does not report any illnesses or injuries, but non-sterile materials in medical kits create a meaningful risk of serious harm including infection.
Plain-English summary
LSL Healthcare Inc. is recalling the Foley Urine Collection Kit, Model/Catalog Number 1555. The recall affects approximately 100 units that were distributed nationwide in Maryland, Illinois, and Minnesota.
The kits contain Webcol Large Alcohol Prep Pads that do not meet sterility requirements. Non-sterile materials in medical procedures can pose a risk of infection.
If you have received this product, do not use it. Contact LSL Healthcare Inc. for further instructions on return or replacement. Healthcare providers should ensure affected kits are removed from use and that patient safety protocols are followed.
The recalled product
- Product
- LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
- Manufacturer
- LSL Healthcare Inc.
- Hazard
- non-sterility
- infection-risk
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 (4)
- Lot Code: Model No. 1555
- UDI-DI 00661392002326
- Lot# 260221
- Expiration Date 02/28/2027 GTIN: (01)00661392002326(10)260221(17)270228
Distribution
Distributed nationwide across the United States.
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