Remington Medical Inc.

Lot numbers: 082943, 083375, 083302, 083232 and 100904.

Gastroenterology-Urology Devices

2

No

Nationwide Distribution

Drainage Bag, Model 600D, 600 mL, Single use, Ethylene Oxide sterilized, Remington Medical, Inc., 6830 Meadowridge Court, Alpharetta, GA 30005. || The Biliary Drainage Bag is used to aid with fluid drainage involving abscess, biliary and nephrostomy. Mechanical failure of this device would result in patient discomfort. This device is not life sustaining no life supporting. The medical device is not intended to be implanted. This medical device has surface contact with the patient. Improper use of this device could cause fluid back-up and result in invasive contact through the catheter. The drainage bag will be used in conjunction with a nephrostomy/biliary drainage catheter.

Lot numbers 092453, 092743, 092956 and 100646

Gastroenterology-Urology Devices

2

No

U.S. Nationwide

Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825M, 18ga (1.3mm) x 25cm (10), Remington Medical, Inc.

Lot numbers: 090212, 091351 and 093136

Gastroenterology-Urology Devices

2

No

U.S. Nationwide

Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820M, 18ga (1.3mm) x 20cm (10), Remington Medical, Inc.

Lot numbers: 083383 and 090582

Gastroenterology-Urology Devices

2

No

U.S. Nationwide

Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825MLL, 18ga (1.3mm) x 25cm (10), Remington Medical, Inc.

Lot numbers: 090162 090289, 905416, 090684, 090758 and 090862.

Gastroenterology-Urology Devices

2

No

U.S. Nationwide

Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820MLL, 18ga (1.3mm) x 20cm (10), Remington Medical, Inc.