LIFE

Non-continuous Serial Numbers between 1178083 and 305080962.

Cardiovascular Devices

3

No

The firm distributes to distributors, hospitals, EMT-Ds and paramedics nationwide. The firm also distibutes the product internationally.

LIFEPAK 12 defibrillator/monitor || Part Numbers: || VLP12-02-000000 through VLP12-02-005003, || AVLP12-02-000000 through AVLP12-02-005003, || DVLP12-02-000000 through DVLP12-02-005003, || EVLP12-02-000000 through EVLP12-02-005003, || FVLP12-02-000000 through FVLP12-02-005003, || LVLP12-02-000000 through LVLP12-02-005003, || PVLP12-02-000000 through PVLP12-02-005003, || UVLP12-02-000000 through UVLP12-02-005003

Part numbers: VLP12-09-000031 through VLP12-09-000048. Serial numbers: 1563 through 5232 (non-contiguous)

Cardiovascular Devices

2

No

The firm distributed devices to medical facilities, fire departments (first responders).

DC Power Adapter for use with the LIFEPAK 12 defibrillator/monitor.

Lot numbers, FA0311031, FA0311032, FA0311034, FA0311035, FA0312026, FA0312034, FA0312041, FA0312042, FA0312051, FA0312052, FA0401006, FA0401019, FA0401026, FA0402026

Product was shipped to one own label distributer in California.

The product is a stainless steel stent mounted on a PTA balloon delivery device. The product is indicated for the palliation of malignant neoplasms in the biliary tree. || The product is labeled as Edwards Lifesciences, LifeStent LP SDS, Biliary Endoprosthesis. Manufactured by ORBUS, MEDICAL TECHNOLOGIES. 5363 NW 35th Ave, Fort Lauderdale, FL, 33309. Ph 954 730-071, www. orbus.com. || Distributed by: Edwards Lifesciences, Irvine, CA 82014-5888. || Ref. Baloon-Expandable Stent and delivery System. || Catalog Numbers || SD186U14D || SD186U24D || SD366U14D || SD366U24D

VLP12-02 Part Numbers all with a Biphasic label on the front of the device

Cardiovascular Devices

3

No

28,835 devices were shipped to 6874 domestic consignees.

LIFEPAK 12 defibrillator/ monitors biphasic

Serial numbers - various, noncontiguous Part numbers - 3005400-XXX, D3005400-XXX, U3005400-XXX

Cardiovascular Devices

3

No

Devices were distributed to 750 domestic consignees dn 16 international consignees.

LIFEPAK 500 AED.