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Terminated

Model 750 24' MRI Reusable/Disposable Circuit Accessory for use with Model 750 Portable Ventilator

FDA Recall Z-0717-2012 · Posted 2012-01-12

Recalling FirmImpact Instrumentation, Inc.
Recall StatusTerminated
Product CodeCAI
Date Initiated2011-10-19
Date Terminated2013-03-11
Product Quantity564 units

Reason for Recall

Model 750 24' MRI Reusable/Disposable Circuit does not have a 510(k).

Firm Action

Impact sent Urgent Device Product Recall letters/return response forms dated 10/19/11 to their consignees. The letter asked customers to return the affected product listed to the address provided within 10 days of receipt of the notification letter. In order to receive proper credit for the returned product, customers should follow the instructions precisely, which includes completing and returning the Recall Tracking Form along with the affected product. If customers have no product to return, they should contact Alan Giordano at [email protected], to inform him of the status of the circuits.

Root Cause

PMA

Distribution Pattern

Nationwide Distribution -- VA, CA, IL, NC, and TX.

Official Source

View FDA Recall →

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

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