Device Recall Regard

034982C Exp Date 2018-07-09; 039451C Exp Date 2018-11-09;

General and Plastic Surgery Devices

2

No

US Distribution to LA and TX.

Regard, Item Number: 800559003, Sterile, ET0648C - Head & Neck - Childrens Santa Rosa

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.