BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures.

FDA device recall Z-0161-2023 · posted 2022-11-01 · Open, Classified

Recall details

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Reason for recall

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

Action taken

Medline disseminated MEDICAL DEVICE RECALL notice by US mail on 09/30/2022, The notices explained the issue and requested the following: "REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-22-149-FG Recall Code: RXXXXXXX 3.Upon completion of the form, please destroy affected product. Your account will receive credit once the response form is submitted. 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Have the customers document and destroy any affected product. You should include your customers quantities on your response form. If you have any questions, please contact the Recall Department at 866-359-1704."

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OJK

Quantity affected

708 kits

Distribution

US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.

Date initiated

2022-09-30

Date posted

2022-11-01

Location

Northfield, IL