Recall Z-2239-2016
Hologic, Inc · initiated May 31, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to collect fluid during a breast biopsy.
Codes / lots: Lot Number: 20150013 and 20150014
Reason for recall
Cracks ATEC Canister Lids.
FDA-determined 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.
Details
- Recall number
- Z-2239-2016
- Initiated
- May 31, 2016
- Posted by FDA
- July 19, 2016
- Terminated
- May 24, 2017
- Product code
- KDQ – Bottle, Collection, Vacuum
- Quantity
- 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 Emirates, Australia, Argentina, Belgium, Canada, Switzerland, Chile, Colombia, Germany, Denmark, France, Great Britain, Hong Kong, Ireland, Israel, Italy, Korea, Kuwait, Lebanon, Malaysia…
- Recalling firm
- Hologic, Inc, Marlborough, MA