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Open, Classified

CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760

FDA Recall Z-1015-2023 · Posted 2023-01-25

Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeOXQ
Date Initiated2022-12-23
Product Quantity1050 kits

Reason for Recall

The kit contained an expired component.

Firm Action

Medline Industries issued a DEVICE RECALL notice to its consignees on 12/23/2022 by First Class Mail. The notice explained the problem and requested the following: "REQUIRED ACTION: -Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. -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

Distribution Pattern

US Nationwide distribution in the states of NY, IN, FL, NJ, IL.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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