Z-1470-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 3, 2022
- Initiation Date
- June 6, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1960
Product Description
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:
Reason for Recall
Kits contain leaking bottles of isopropyl alcohol
Distribution Pattern
US Nationwide distribution.
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