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
This recall is currently active, issued September 11, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- June 27, 2024
- Posted
- September 11, 2024
- Recall Number
- Z-3120-2024
- Quantity
- 720 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
XXX
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
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
Root Cause
Process control
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.