—#209536

Product

Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack Number DYNJ59921B; b) AMB VITRECTOMY, Pack Number DYNJ59921BH; c) AMB OCULOPLASTICS MUSC, Pack Number DYNJ59923B; d) AMB OCULOPLASTICS MUSC, Pack Number DYNJ59923BH; e) AMB CUSTOM EYE, Pack Number DYNJ59924B; f) AMB CUSTOM EYE, Pack Number DYNJ59924BH; g) CATARACT-30843, Pack Number DYNJVB91139

FDA product code: OJK — Eye Tray
Device class: Class 2
Medical specialty: Ophthalmic
Affected lot / code info: a) DYNJ59921B: UDI/DI case 40195327037148, UDI/DI each 10195327037147, Lot Numbers: 23LBS025, 24ABY181; b) DYNJ59921BH: UDI/DI case 40195327037148, UDI/DI each 10195327037147, Lot Numbers: 23LBS025, 24ABY181; c) DYNJ59923B: UDI/DI case 40195327043217, UDI/DI each 10195327043216, Lot Numbers: 23LBF664, 23LBS053, 24ABY182; d) DYNJ59923BH: UDI/DI case 40195327043217, UDI/DI each 10195327043216, Lot Numbers: 23LBF664, 23LBS053, 24ABY182; e) DYNJ59924B: UDI/DI case 40195327036967, UDI/DI each 10195327036966, Lot Numbers: 23LBD909; f) DYNJ59924BH: UDI/DI case 40195327036967, UDI/DI each 10195327036966, Lot Numbers: 23LBD909; g) DYNJVB91139: UDI/DI case 40195327607105, UDI/DI each 10195327607104, Lot Numbers: 24CLA670, 24CLA895

Why it was recalled

XXX

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Panama.

Timeline

Recall initiated: 2024-06-27
Posted by FDA: 2024-09-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209536. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.