IV Start Kit with Non-Sterile Alcohol Prep Pads Recalled
LSL Healthcare is recalling IV Start Kits containing Webcol Large Alcohol Prep Pads due to non-sterility concerns. The affected kits were distributed nationwide in Maryland, Illinois, and Minnesota.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II medical device recall involving sterility failure in a device used in invasive medical procedures. Non-sterile materials in IV start kits create a significant risk of infection and potential hospitalization, meeting the criteria for Severe classification.
Plain-English summary
LSL Healthcare Inc. is recalling its IV Start Kit, Model/Catalog Number 3131, due to the presence of Webcol Large Alcohol Prep Pads that do not meet sterility requirements. Approximately 2,200 units were distributed nationwide in the states of Maryland, Illinois, and Minnesota.
The non-sterile alcohol prep pads pose a risk of infection when used in medical procedures that require sterile conditions. Non-sterile materials used in IV insertion procedures could compromise patient safety.
Consumers and healthcare facilities should cease use of affected kits immediately. The recalled product can be identified by Lot Code Model No. 3131, UDI-DI 00661392054271, Lot #6A3139, with expiration date 01/21/2028, and GTIN (01)00661392054271(10)6A3139(17)280121. Healthcare providers should contact LSL Healthcare Inc. for instructions on returning or disposing of affected units.
The recalled product
- Product
- LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
- 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. 3131
- UDI-DI 00661392054271
- Lot#6A3139
- Expiration Date 01/21/2028 GTIN: (01)00661392054271(10)6A3139(17)280121
Distribution
Distributed nationwide across the United States.