Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1473-2022Class II

Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE Model/Catalog Number: DYNJ907150

MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-06-06 / Open, Classified

MEDLINE INDUSTRIES, LP - SPT began a recall of Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE Model/Catalog Number: DYNJ907150 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-1473-2022
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Product
Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE Model/Catalog Number: DYNJ907150
Product code
FDE Laparoscopy Kit
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
54 units
Distribution
US Nationwide distribution.
Product codes and lots
Lot Code: 21FBJ077, 21GBJ337, 21GBJ338

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1473-2022
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