Recall Z-1471-2022
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: 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
Codes / lots: Lot Code: a. Model Number DYNJ36725B, Lot codes: 19UBB149, b. Model Number DYNJ905860A, Lot codes: 22OBG246, 21LBU048, 21GBI196, 21KBK242, 21EBH567
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-1471-2022
- Initiated
- June 6, 2022
- Product code
- OFF – Central Venous Catheter Tray
- Quantity
- 288 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Medline Industries, LP - SPT, Waukegan, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1470-2022 Class II | Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number…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 |