Device Recall Regard

038832B Exp Date 2018-06-30; 040636B Exp Date 2018-10-31

General and Plastic Surgery Devices

2

No

US Distribution to LA and TX.

Regard, Item Number: 880331002, Sterile, OR0762B - Total Knee - OSU

23735

General and Plastic Surgery Devices

2

No

Distributed to one customer in Lake Charles, LA and one customer in Spartanburg, SC.

Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.

025072B

General and Plastic Surgery Devices

2

No

Distributed to one customer in Lake Charles, LA and one customer in Spartanburg, SC.

Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B.; Used in cardiovascular surgical procedures.

Lot 25787E, exp. date 1/19/2017

General and Plastic Surgery Devices

2

No

Product was distributed to one customer in Oklahoma.

Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.

23076, 25396, 26210, and 27186

General Hospital and Personal Use Devices

1

No

Distributed in Texas and Louisiana.

Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.