Circumcision trays recalled over open swabstick applicator seals
Medline is recalling 168 units 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 Mercy Circumcision Tray under Medline kit SKU CIT6135B.
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 168 units under UDI/DI 10653160990666, lot number 25EBC648. 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: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Procedure kit
- Affected units
- 168
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 10653160990666
- Lot Number 25EBC648
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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