PowerGlide and central line kits recalled over open swabstick seals
Medline is recalling 7,380 kits of convenience kits containing BD ChloraPrep Triple Swabsticks, which BD determined may 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 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 PowerGlide Dressing Change Kit under Medline kit SKU DYNDH1576 and the Central Line Tray w/ ChlrP Swb under SKU RWM-DC57KC.
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 7,380 kits, with kit SKUs, UDI/DI codes and lot numbers recorded in the enforcement record. 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: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE TRAY W/ CHLRP SWB, Kit SKU RWM-DC57KC.
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Procedure kit
- Affected units
- 7,380
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 (6)
- 1) Kit SKU DYNDH1576
- UDI/DI 10193489437041
- Lot Number 25EBP737
- 2) Kit SKU RWM-DC57KC
- UDI/DI 10889942582013
- Lot Number 25EBE082.
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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