Recall Z-1470-2022
Medline Industries, LP - SPT · initiated June 6, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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:
Codes / lots: 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
Reason for recall
Kits contain leaking bottles of isopropyl alcohol
FDA-determined cause: Under Investigation by firm
Action taken
The firm's consignees were notified by US mail on 06/06/2022 and instructed to destroy any affected kits on hand in accordance with their local and state regulations.
Details
- Recall number
- Z-1470-2022
- Initiated
- June 6, 2022
- Product code
- OEZ – Cardiovascular Procedure Kit
- Quantity
- 1960
- Distribution
- US Nationwide distribution.
- Recalling firm
- Medline Industries, LP - SPT, Waukegan, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1471-2022 Class II | Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes:…Kits contain leaking bottles of isopropyl alcohol | 06/06/2022Open, Classified |
| Z-1472-2022 Class II | Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ0689093V, b. EENT…Kits contain leaking bottles of isopropyl alcohol | 06/06/2022Open, Classified |
| Z-1473-2022 Class II | Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE Model/Catalog…Kits contain leaking bottles of isopropyl alcohol | 06/06/2022Open, Classified |
| Z-1474-2022 Class II | Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO…Kits contain leaking bottles of isopropyl alcohol | 06/06/2022Open, Classified |
| Z-1475-2022 Class II | Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRAY W/CHG…Kits contain leaking bottles of isopropyl alcohol | 06/06/2022Open, Classified |
| Z-1476-2022 Class II | Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT NEUR FUS LUM…Kits contain leaking bottles of isopropyl alcohol | 06/06/2022Open, Classified |
| Z-1477-2022 Class II | Kits contain leaking bottles of isopropyl alcohol | 06/06/2022Open, Classified |