Device product
Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes: 19UBB149, b. KIT LB SHUNT, Model NumberDYNJ905860A, Lot codes: 22OBG246, 21LBU048, 21GBI196, 21KBK242, 21EBH567 Model/Catalog Number: a. Model Number DYNJ36725B, b. Model Number DYNJ905860A
Z-1471-2022
Product summary
- Event
- Event 90516
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 288 units
- Official record key
device-enforcement:Z-1471-2022
Official wording
Reason: Kits contain leaking bottles of isopropyl alcohol
Code information: Lot Code: a. Model Number DYNJ36725B, Lot codes: 19UBB149, b. Model Number DYNJ905860A, Lot codes: 22OBG246, 21LBU048, 21GBI196, 21KBK242, 21EBH567
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Kits contain leaking bottles of isopropyl alcohol