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Terminated

Centurion- Biopsy Tray TRIBT170 BIOPSY TRAY

FDA Recall Z-1070-2020 · Posted None

Recall StatusTerminated
Product CodeLRP
Date Initiated2019-12-11
Date Terminated2020-09-04
Product Quantity60

Reason for Recall

Incomplete seals on the sterile package may compromise the sterility

Firm Action

Centurion issued a notification emailed to Medline Industries, Centurion's parent company. Centurion issued mailing letters via First Class Mail beginning on 12/12/2019, letter states reason for recall, health risk and action to take: Please identify all inventory that you have within your possession and segregate it in a location where it cannot be accessed for use. 2) If you have transferred possession of this product to another individual, to another department or to another location in your organization, you are required by FDA regulations to notify them of this recall communication. Please ask that any affected product be returned to you for collection. 3) Affected product is not to be returned to Centurion, and should be destroyed/discarded. Document the destruction of all product on the enclosed accountability record. 4) Please complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter, Director of Quality Assurance Centurion Medical Products Corporation, (517) 546-5400 Ext.1122.

Root Cause

Packaging process control

Distribution Pattern

Nationwide Foreign: GHANA

Official Source

View FDA Recall →

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

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