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

FDA device recall Z-2239-2016 · posted 2016-07-19 · Terminated

Recall details

Recalling firm

Hologic, Inc

Reason for recall

Cracks ATEC Canister Lids.

Action taken

Customers were notified of the recall via certified letter beginning on May 31, 2016. The letter requests that customers immediately inventory your supplies of the Recalled product in all appropriate areas and cease use of all affected stock. In addition, they are asked to complete the enclosed Recall Response Card indicating whether you have any of the Recalled product on hand, as well as the quantity of product that you have in stock.

Root cause

Process control

Status

Terminated

Product code

KDQ

Quantity affected

16,870

Distribution

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

Date initiated

2016-05-31

Date posted

2016-07-19

Date terminated

2017-05-24

Location

Marlborough, MA