GE Medical Systems Information Technologies

lot number 2290

Cardiovascular Devices

Product was distributed to the firm''s related warehouse in Texas and then on to 20 distributors and 8 hospitals in the United States and also one international distributor in Japan.

Critikon brand Adult, DURA-CUF, product code 2790, used as an arm cuff in association with a blood pressure monitor.

Lot numbers 01-08 through 02-16 which are embossed into the power cord metal blades and also those with no lot numbers.

Cardiovascular Devices

2

No

The recalled AC power cords were distributed to approximately 2600 Domestic hospital accounts nationwide and 180 international accounts.

Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug.

All serial numbers are involved.

Obstetrical and Gynecological Devices

2

No

The monitors were distributed to 8 hospitals in SC, WI, CA, MN, TX, MD and NV, as well as two hospitals in France.

GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is

Lot 0601

Product was distributed to one distributor in Oregon.

Infant reusable blood pressure cuffs, one tube, male slip luer connector, P/N 2930 , manufactured for Welch Allyn Protocol, Inc. and labeled in part: '***Reusable Blood Pressure Cuffs Infant 50 Cuffs REF 008-0625-00 PROTOCOL SYSTEMS, INC. Beaverton, OR 97008-7107 USA Assembled in Mexico***.'

Lot 3910

Product was distributed to 69 domestic hospitals nationwide including four military accounts. Also product was distributed 6 accounts in Canada, one in Thailand, one in Chile, one in Japan and one in singapore.

Critikon brand Omni-Sat Adult, Semi-Disposable Sensor - P/N 009136