Device product
Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, Kit SKU DT22710; 2) LINE KIT, Kit SKU DYNDA1857A; 3) PICC REMOVAL KIT, Kit SKU DYNDC1978A; 4) PORT ACCESS TRAY, Kit SKU DYNDC2367; 5) NICU CENTRAL LINE TRAY, Kit SKU DYNDC2407B; 6) CVC DRESSING CHANGE W/ TEG CHG, Kit SKU DYNDC3222A; 7) PICC PROCEDURE PACK, Kit SKU DYNJ59067A; 8) PICC PROCEDURE PACK, Kit SKU PHS950205004B.
Z-1329-2026
Product summary
- Event
- Event 98284
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7570 kits
- Official record key
device-enforcement:Z-1329-2026
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 DT22710, Lot Numbers: 25EBC812; 2) Kit SKU DYNDA1857A, Lot Numbers: 25FBH991; 3) Kit SKU DYNDC1978A, Lot Numbers: 25EBC577; 4) Kit SKU DYNDC2367, Lot Numbers: 25EBS434; 5) Kit SKU DYNDC2407B, Lot Numbers: 25FMG170; 6) Kit SKU DYNDC3222A, Lot Numbers: 25EBK184; 7) Kit SKU DYNJ59067A, Lot Numbers: 25EBM461, 25EBD386; 8) Kit SKU PHS950205004B, Lot Numbers: 25FMD059.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
open seal