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Class I Medical Device Recall: Millar Instruments Inc., Mikro-Tip Angiographic Catheter, Model SPC-454D and SPC-454F

Posted Mar 31 2011 12:00am

Recall Class: Class I

Date Recall Initiated: March 8, 2011

Product: Mikro-Tip Angiographic Catheter, Model SPC-454D and SPC-454F

This recall includes all catheters of these models that did not expire prior to March 2011.

See Firm Press Release under Additional Links below.

This product was manufactured and distributed from March 1, 2009 through February, 28, 2011.

Use: This device measures pressure within the blood vessels. It is capable of delivering high-speed injection of material that is not absorbed into the body (radiopaque contrast media). This material is then used to view blood vessels.

Recalling Firm:

Millar Instruments, Inc.
6001-A Gulf Freeway
Houston, Texas 77023

Reason for Recall: There is a possibility that small particles (debris) may be found inside the catheter. This foreign debris can potentially travel (embolize) from the catheter to tissues, blood vessels, limbs and organs. This could lead to a decreased blood supply to these structures which can result in serious injury and /or death.

Public Contact: Questions may be directed to the Millar Instruments at 1-800-669-2343 from 8:00 AM to 5:00 PM Central Daylight Time.

FDA District: Dallas

FDA Comments:

On March 8, 2011, the company notified their customers and distributors by email and sent each a hardcopy of the email. The notice described the product, problem, and actions to be taken.

Customers and distributors were instructed to return the catheters to the company or report back to the company if the catheters have been used. Unused catheters should be returned to the company for inspection.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s Safety Information and MedWatch Adverse Event Reporting Program either online, by regular mail or by FAX.

Additional Links:

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