Device product
Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088
Z-1333-2026
Product summary
- Event
- Event 98284
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4300 kits
- Official record key
device-enforcement:Z-1333-2026
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 10198459230363, Lot Numbers: 25EBU508, 25EBE330.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
open seal