Port and line access kits recalled over open swabstick applicator seals
Medline is recalling 7,570 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 Cancer Service Port Kit under Medline kit SKU DT22710, a Line Kit under SKU DYNDA1857A, a PICC Removal Kit under SKU DYNDC1978A and a Port Access Tray under SKU DYNDC2367, 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 7,570 kits, with kit SKUs 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) CANCER SERVICE PORT KIT, Kit SKU DT22710; 2) LINE KIT, Kit SKU DYNDA1857A; 3) PICC REMOVAL KIT, Kit SKU DYNDC1978A; 4) PORT ACCESS TRAY, Kit SKU DYNDC2367; 5) NICU CENTRAL LINE TRAY, Kit SKU DYNDC2407B; 6) CVC DRESSING
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Procedure kit
- Affected units
- 7,570
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 (17)
- 1) Kit SKU DT22710
- Lot Numbers: 25EBC812
- 2) Kit SKU DYNDA1857A
- Lot Numbers: 25FBH991
- 3) Kit SKU DYNDC1978A
- Lot Numbers: 25EBC577
- 4) Kit SKU DYNDC2367
- Lot Numbers: 25EBS434
- 5) Kit SKU DYNDC2407B
- Lot Numbers: 25FMG170
- 6) Kit SKU DYNDC3222A
- Lot Numbers: 25EBK184
- 7) Kit SKU DYNJ59067A
- Lot Numbers: 25EBM461
- 25EBD386
- 8) Kit SKU PHS950205004B
- Lot Numbers: 25FMD059.
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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