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U.S. Department of Health and Human Services

Class 2 Device Recall BAUSCH LOMB

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  Class 2 Device Recall BAUSCH LOMB see related information
Date Initiated by Firm September 30, 2022
Date Posted November 01, 2022
Recall Status1 Open3, Classified
Recall Number Z-0156-2023
Recall Event ID 90946
Product Classification Eye tray - Product Code OJK
Product BAUSCH + LOMB PHACO PACK, REF LYN011PHNHD. Convenience kit used in surgical procedures.
Code Information GTIN (01) 40193489234405, Lot Number 22DBM505
Recalling Firm/
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Karin Johnson
866-359-1704
Manufacturer Reason
for Recall
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
FDA Determined
Cause 2
Under Investigation by firm
Action 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."
Quantity in Commerce 160 kits
Distribution US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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