Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
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
FDA enforcement reports joined to recall event Z-1471-2022
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1470-2022Class IIOngoingVoluntary: Firm initiated
Z-1471-2022Class IIOngoingVoluntary: Firm initiated
Z-1472-2022Class IIOngoingVoluntary: Firm initiated
Z-1473-2022Class IIOngoingVoluntary: Firm initiated
Z-1474-2022Class IIOngoingVoluntary: Firm initiated
Z-1475-2022Class IIOngoingVoluntary: Firm initiated
Z-1476-2022Class IIOngoingVoluntary: Firm initiated
Z-1477-2022Class IIOngoingVoluntary: Firm initiated