Hologic

Model: InSight and InSight 2, Affected:

Model: , Affected:

Model: , Affected: Lot No: 20150013

Lot Number: 20150013 and 20150014

General Hospital and Personal Use Devices

2

No

Worldwide distribution. US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY OUS: United Arab Emirates, Australia, Argentina, Belgium, Canada, Switzerland, Chile, Colombia, Germany, Denmark, France, Great Britain, Hong Kong, Ireland, Israel, Italy, Korea, Kuwait, Lebanon, Malaysia, Netherlands, New Zealand, Qatar, Singapore, Thailand, Taiwan, and South Africa.

ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to collect fluid during a breast biopsy.

Lot number: 15C10RA.

Gastroenterology-Urology Devices

2

No

Nationwide.

Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.