Atlas FDA

Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack Number DYNJ599

FDA device recall Z-3120-2024 · posted 2024-09-11 · Open, Classified

Recall details

Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Reason for recall
XXX
Action taken
Medline Industries issued a MEDICAL DEVICE RECALL notice to its consignees on 06/27/2024 via US mail and email. The notice explained the problem with the device, potential risk to the patient, and requested the consignee immediately check their stock for the affected item number and the affected lot numbers and destroy any affected inventory. Distributors were directed to notify their customers of the recall and request the affected products be destroyed. For questions: contact the Recall Department at 866-359-1704 or recalls@medline.com.
Root cause
Process control
Status
Open, Classified
Product code
OJK
Quantity affected
720 units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Date initiated
2024-06-27
Date posted
2024-09-11
Location
Northfield, IL

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