Device 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.
Z-1331-2026
Product summary
- Event
- Event 98284
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7380 kits
- Official record key
device-enforcement:Z-1331-2026
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: 1) Kit SKU DYNDH1576, UDI/DI 10193489437041, Lot Number 25EBP737; 2) Kit SKU RWM-DC57KC, UDI/DI 10889942582013, Lot Number 25EBE082.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
open seal