Device product
Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B
Z-1336-2026
Product summary
- Event
- Event 98284
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 168 units
- Official record key
device-enforcement:Z-1336-2026
Official wording
Reason: Medline Industries, LP 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.
Code information: UDI/DI 10653160990666, Lot Number 25EBC648
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
open seal