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U.S. Department of Health and Human Services

Class 2 Device Recall Model 750 24' MRI Reusable/Disposable Circuit

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  Class 2 Device Recall Model 750 24' MRI Reusable/Disposable Circuit see related information
Date Initiated by Firm October 19, 2011
Date Posted January 12, 2012
Recall Status1 Terminated 3 on March 11, 2013
Recall Number Z-0717-2012
Recall Event ID 60767
Product Classification Circuit, breathing (w connector, adaptor, y piece) - Product Code CAI
Product Model 750 24' MRI Reusable/Disposable Circuit

Accessory for use with Model 750 Portable Ventilator
Code Information p/n 802-1750-05, no expiration ; 802-1750-24, five years
Recalling Firm/
Manufacturer		 Impact Instrumentation, Inc.
23 Fairfield Pl
West Caldwell NJ 07006-6206
For Additional Information Contact Mr. Alan Giordano
973-882-1212
Manufacturer Reason
for Recall		 Model 750 24' MRI Reusable/Disposable Circuit does not have a 510(k).
FDA Determined
Cause 2		 PMA
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 agiordano@impactii.com, to inform him of the status of the circuits.
Quantity in Commerce 564 units
Distribution Nationwide Distribution -- VA, CA, IL, NC, and TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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