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Terminated

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

FDA Recall Z-2239-2016 · Posted 2016-07-19

Recalling FirmHologic, Inc
Recall StatusTerminated
Product CodeKDQ
Date Initiated2016-05-31
Date Terminated2017-05-24
Product Quantity16,870

Reason for Recall

Cracks ATEC Canister Lids.

Firm Action

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

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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