Recalls / —

—#197226

Product

GEO-MED CATARACT PACK, REF 89-5790.08

FDA product code

LRO — General Surgery Tray

Device class

Class 2

Medical specialty

General, Plastic Surgery

Affected lot / code info

Lot Numbers: 55966890 exp 02/01/2023; 56020131 exp 03/01/2023; 56184435 exp 02/01/2023; 56618387 exp 06/01/2023; 57001493 exp 06/01/2023; 57227821 exp 09/01/2023; 57466709 exp 09/01/2023; 57589522 exp 09/01/2023; 57749750 exp 12/01/2023; 5786389 ezp 12/01/2023

Why it was recalled

XXX

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The firm issued an URGENT RECALL NOTICE to its consignees on 11/03/2022 by email and US mail. 1) Using the attached Affected Products Listing Spreadsheet, identify affected part/lot numbers in your inventory and place in quarantine to prevent further use. 2) DeRoyal will contact you to schedule time to affix labels to all affected product. These labels indicate that, at the time of use, the affected product should be removed from the kit/tray and destroyed. These products should be destroyed according to your facility, local, state and federal regulations. 3) DeRoyal representative will determine kits/trays and affected lot numbers which require the labeling indicating to remove 3M Health Care item. 4) The completed the NOTICE OF DESTRUCTION FORM shall be emailed to recalls@deroyal.com no later than 12/8/2022. PLEASE COMPLETE THIS FORM EVEN IF YOU NO LONGER HAVE ANY INVENTORY. 5) The remaining items in the kit/tray are unaffected and may still be used. Distributors were asked to perform the following: "1) Using the attached Distributor Affected Products Listing Spreadsheet, identify affected part/lot numbers in your inventory and request placement in quarantine to prevent further use. 2) Please notify us with the quantity of affected cases, product and lot numbers in your inventory to which labels will need to be applied. Email this to recalls@deroyal.com no later than 11/21/2022. We will immediately send labeling for you to apply to case and each pack contained within. 3) These labels indicate that, at the time of use, the affected product should be removed from the kit / tray and destroyed. 4) The remaining items in the kit/tray are unaffected and may still be used. 5) If you have questions or need assistance with the recall, please contact your DeRoyal Supplier Relations contact, customer service at 888.938.7828, or email us at recalls@deroyal.com.

Recalling firm

Firm

DeRoyal Industries Inc

Address

200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

Distribution pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

Timeline

Recall initiated

2022-11-03

Posted by FDA

2022-12-15

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #197226. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.