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

FDA device recall Z-0717-2012 · posted 2012-01-12 · Terminated

Recall details

Recalling firm

Impact Instrumentation, Inc.

Reason for recall

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

Action taken

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 agiordano@impactii.com, to inform him of the status of the circuits.

Root cause

PMA

Status

Terminated

Product code

CAI

Quantity affected

564 units

Distribution

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

Date initiated

2011-10-19

Date posted

2012-01-12

Date terminated

2013-03-11

Location

West Caldwell, NJ