Device product
Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109
Z-1327-2026
Product summary
- Event
- Event 98284
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1350 kits
- Official record key
device-enforcement:Z-1327-2026
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 10193489918113, Lot Number 25EBD613
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
open seal