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Open, Classified

Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access

FDA Recall Z-2249-2023 · Posted 2023-07-28

Recalling FirmCreganna Medical Devices
Recall StatusOpen, Classified
Product CodeDYB
Date Initiated2023-06-22
Product Quantity194 units

Reason for Recall

Three lots of product may be labeled with an incorrect expiration day

Firm Action

Creganna Medical notified its sole consignee on 06/22/2023 via email. The notice explained the problem with the product and informed the consignee of their intention to collaboratively conduct a recall. The sole consignee is notifying their customers by letter delivered by FedEX on 06/28/2023. The product is to be returned to the consignee.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the state of AZ.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K152913GORE TIPS Set, GORE TIPS Sheath, GORE TIPS NeedleCreganna Medical Aslo Business AS Cregganna Tactx Medical · 2016-07-21

Official Source

View FDA Recall →

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

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