Dressing change trays recalled over open swabstick applicator seals
Medline is recalling 8,445 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 LVAD Dressing Change Tray under Medline kit SKU DM320C, the Port and IO Access Dressing Kit under SKU DT15780A, the Port-A-Cath Dressing Change Tray under SKU DT16615 and a Large Bore kit, among the kits listed in the enforcement record.
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 8,445 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: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DRESSING KI, Kit SKU DT15780A; 3) PORT-A-CATH DRESSING CHANGE TR, Kit SKU DT16615; 4) LARGE BORE CENTRAL LINE DRSG C, Kit SKU DT19660; 5) CENTRAL LINE…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Procedure kit
- Affected units
- 8,445
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 (20)
- 1) Kit SKU DM320C
- UDI/DI 10653160997504
- Lot Number 25EBQ881
- 2) Kit SKU DT15780A
- UDI/DI 10653160323303
- Lot Number 25EBH827
- 3) Kit SKU DT16615
- UDI/DI 10653160259268
- Lot Number 25EBC730
- 4) Kit SKU DT19660
- UDI/DI 10653160283041
- Lot Number 25EBD629
- 5) Kit SKU DT19665
- UDI/DI 10653160283263
- Lot Number 25EBU086
- 6) Kit SKU DT21495
- UDI/DI 10653160320593
- Lot Number 25EMJ081
- 7) Kit SKU DT22510A
- UDI/DI 10193489499247
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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