Device product
Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number DYNJ902880J, c. VASCULAR CDS, Model Number DYNJ902880K, d. OPEN HEART A & B, Model Number DYNJ904831F, e. OPEN HEART MHS, Model Number DYNJ905394A, f. OPEN HEART MHS, Model Number DYNJ905394B, g. OPEN HEART WPH, Model Number DYNJ908168 Model/Catalog Number: Model Numbers: a. CDS984642, b. DYNJ902880J, c. DYNJ902880K, d. DYNJ904831F, e. DYNJ905394A, f. DYNJ905394B, g. DYNJ908168 Product Description: convenience kits labeled as follows:
Z-1470-2022
Product summary
- Event
- Event 90516
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1960
- Official record key
device-enforcement:Z-1470-2022
Official wording
Reason: Kits contain leaking bottles of isopropyl alcohol
Code information: a. Model Number CDS984642, Lot codes: 19JBB553 b. Model Number DYNJ902880J, Lot codes: 21FBR331, 21HBD394, 21IBP835, 21KBM214, 21DBE158 c. Model Number DYNJ902880K, Lot codes: 22BBD964, 21KBV788, 21LBN478 e. Model Number DYNJ904831F, Lot codes: 22DBT300, 22DBU172, 22BBO313, 21JBX260, 21KBO308 f. Model Number DYNJ905394A, Lot codes: 21HBJ840, 21IBU071, 21JBY922, 21DBS569, 21FBA011 g. Model Number DYNJ905394B, Lot codes: 22ABM646 h. Model Number DYNJ908168, Lot codes: 22EBB265
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Kits contain leaking bottles of isopropyl alcohol