Z-1471-2022Class II
Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes: 19UBB149, b. KIT LB...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-06-06 / Open, Classified
MEDLINE INDUSTRIES, LP - SPT began a recall of Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes: 19UBB149, b. KIT LB SHUNT, Model NumberDYNJ905860A, Lot codes... on . FDA classified it as Class II and gives the reason as "Kits contain leaking bottles of isopropyl alcohol". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-1471-2022
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- 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
- Product code
- OFF Central Venous Catheter Tray
- Reason for recall
- Kits contain leaking bottles of isopropyl alcohol
- FDA root cause
- Under Investigation by firm
- Action
- 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.
- Quantity in commerce
- 288 units
- Distribution
- US Nationwide distribution.
- Product codes and lots
- Lot Code: a. Model Number DYNJ36725B, Lot codes: 19UBB149, b. Model Number DYNJ905860A, Lot codes: 22OBG246, 21LBU048, 21GBI196, 21KBK242, 21EBH567
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1470-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1471-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1472-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1473-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1474-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1475-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1476-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1477-2022 | Class II | Ongoing | Voluntary: Firm initiated |
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