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Terminated

FIRMap" Catheter, 60mm Basket

FDA Recall Z-1213-2022 · Posted None

Recalling FirmAbbott
Recall StatusTerminated
Product CodeMTD
Date Initiated2022-04-28
Date Terminated2024-06-18
Product Quantity40 units

Reason for Recall

Incorrect product labeling.

Firm Action

The firm sent out a "MEDICAL DEVICE RECALL" notification letter dated 04/28/2022 via hand delivery to the US customers. OUS consignee notification is via hand delivery. A copy of the English version of the OUS letter is attached and this letter was translated into the appropriate languages for delivery. The letter instructs the consignee to stop using the remaining inventory, complete and return the acknowledgement form by email: [email protected], and return all unused devices. Should you have questions about this issue, please contact your local Abbott Representative or Abbot Support at 1-888-655-3500 (Option 2) (U.S.), 8:30 a.m. - 5:30 p.m. Central Time Monday through Friday.

Root Cause

Process control

Distribution Pattern

US Nationwide Distribution to states of: MO, CA, OH, WA and OUS internationally to Italy and Netherlands.

Official Source

View FDA Recall →

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

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