Central line dressing kits recalled over open swabstick applicator seals
LSL Healthcare is recalling 1,400 Central Line Dressing Kits because the BD ChloraPrep Triple Swabsticks inside exhibit an open seal on the applicator packaging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: an open seal on an antiseptic applicator used for central line placement compromises the sterile barrier, and no injuries are reported.
Plain-English summary
The LSL Healthcare Central Line Dressing Kit, model/catalog number 2519CP, a medical procedure convenience kit, is being recalled by LSL Healthcare Inc.
The reason given in the enforcement record is that BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the applicators.
The record lists 1,400 kits under model 2519CP, UDI-DI 00661392048157, lot 5G3119, with an expiration date of 7/31/26. The record gives distribution as US nationwide in the state of Idaho. The FDA has classified the action as Class II.
An open seal on a skin antiseptic applicator used before central line placement means its sterile barrier cannot be assured. The enforcement record reports no injuries. Facilities should quarantine the affected lot and follow LSL Healthcare's instructions.
The recalled product
- Product
- LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit
- Manufacturer
- LSL Healthcare Inc.
- Category
- Medical Device — Procedure kit
- Affected units
- 1,400
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. 2519CP
- UDI-DI 00661392048157
- Lot# 5G3119
- Expiration Date 7/31/26 GTIN: (01)00661392048157(10)5G3119(17)260731
Distribution
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