ClearanceBrief
Recall Z-1473-2022 ยท FDE Laparoscopy Kit

MEDLINE INDUSTRIES, LP - SPT

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

DateJun 6, 2022
StatusOpen, Classified
ReasonKits contain leaking bottles of isopropyl alcohol
Root causeUnder Investigation by firm
ActionThe 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.
Quantity54 units
DistributionUS Nationwide distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.