Catheter securement dressing kits recalled over open swabstick seals
Medline is recalling 1,350 kits of convenience kits containing BD ChloraPrep Triple Swabsticks, which BD determined may exhibit an open seal on the applicator packaging.
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: Scored 3 under the risk-of-harm criterion: an open seal on an antiseptic applicator compromises the sterile barrier, and no injuries are reported.
Plain-English summary
Medline medical convenience kits are being recalled by Medline Industries, LP, covering the Adult Cath Securement Drsg kit under Medline kit SKU DYNDC3109.
The record states Medline is issuing a recall for specific items and lots of Medline kits containing BD ChloraPrep Triple Swabsticks, which BD determined may exhibit an open seal on the packaging of the applicators.
The record lists 1,350 kits under UDI/DI 10193489918113, lot number 25EBD613. Distribution was nationwide in the United States. The FDA has classified the action as Class II.
An open seal on a skin antiseptic applicator means its sterile barrier cannot be assured. The enforcement record reports no injuries. Facilities should quarantine affected kits and follow Medline's instructions.
The recalled product
- Product
- Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Procedure kit
- Affected units
- 1,350
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 (2)
- UDI/DI 10193489918113
- Lot Number 25EBD613
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 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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