Device Recall IL

Product Code: a.) TIN3015/ LOT 0000836578, 0000841213, 0000841215, 0000842719, 0000842721, 0000845423, 0000848061, 0000849715, 0000850938, 0000852076, 0000854859; Product Code: b.) TIN3018/ LOT 0000836574, 0000841212, 0000852078

General and Plastic Surgery Devices

1

No

Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam

ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE;

Model Numbers M0004EPiL120CART0, serial number 4037; H749iLab120CART0, serial numbers 4041, 4020, 4056, 4018, 4037; H749iLab120CARTD0, serial number 4064; H749iLab120CARTR0, serial number 4022; H749iLab120INS0, serial numbers 4016, 4015, 4008, 4043.

Cardiovascular Devices

2

No

Product was distributed to 13 US consignees and 10 foreign consignees.

iLab Utrasound Imaging System, software controlled Imaging Catheter.

ID #: 6260030000.  Lot Numbers:  A1ILJPT001, H0ILJPT005, and K0ILJPT006.

Hematology and Pathology Devices

2

No

Worldwide Distribution: (USA) Nationwide Distribution including the countries of; Austria, Australia, Canada, Switzerland, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Korea, Liechtenstien, Libya, Netherlands, Norway, Oman,Portugal, Qatar, Saudi Arabia, Sweden, Turkey, Taiwan, and South Africa.

IL GEM PCL/PCL Plus - Gem Test PT Cartridge || ITC-Nexus Dx || A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time.

Instrument Serial No. M70106, M00533L, M70114. Lot No. Shipped: K103313, K103461, K103404, K103487.

Hematology and Pathology Devices

2

No

US: MD, NY Non-US: France

Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

Serial numbers: 100268621 to 100717475

General and Plastic Surgery Devices

2

No

Worldwide Distribution.

ILED Surgical Light, Model numbers: ILED3, ILED5 and ILED5K