SPS Sterilization, Inc: Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.

Is my product affected?

Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.

• UPC 16401032017

Check against the official notice below — it lists the full affected range.

What happened

SPS Sterilization, Inc. is recalling Edwards Lifesciences EZ Glide Aortic Cannula devices (24F x 37.6CM) that were resterilized. The devices have an expiration date on their labeling that exceeds the actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life. Six units total were distributed in the United States to Arizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia, and West Virginia under Code Number EZC24A-R, Lot Number 59634962, with serial numbers ranging from 16401032017-01 through 16401032017-37.

The recall record does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

Details from the source

Reason for recall: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life. Distribution: US distribution to AZ, CA, FL, OH, PA, TX, VA, WV Quantity: 6 units total Lot/code info: Code Number EZC24A-R; Lot Number 59634962; Serial Numbers 16401032017-01, 16401032017-02, 16401032017-03, 16401032017-04, 16401032017-05, 16401032017-06, 16401032017-07, 16401032017-08, 16401032017-09, 16401032017-10, 16401032017-11, 16401032017-12, 16401032017-13, 16401032017-14, 16401032017-15, 16401032017-16, 16401032017-17, 16401032017-18, 16401032017-19, 16401032017-20, 16401032017-21, 16401032017-22, 16401032017-23, 16401032017-24, 16401032017-25, 16401032017-26, 16401032017-27, 16401032017-28, 16401032017-29, 16401032017-30, 16401032017-31, 16401032017-32, 16401032017-33, 16401032017-34, 16401032017-35, 16401032017-36, 16401032017-37

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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