RecallDepth

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

Company
Hologic, Inc
Recall Initiated
May 31, 2016
Posted
July 19, 2016
Terminated
May 24, 2017
Recall Number
Z-2239-2016
Quantity
16,870
Firm Location
Marlborough, MA

Reason for Recall

Cracks ATEC Canister Lids.

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 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.

Lot / Code Info

Lot Number: 20150013 and 20150014

Root Cause

Process control

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.

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