Device product
ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to collect fluid during a breast biopsy.
Z-2239-2016
Product summary
- Firm
- Hologic, Inc
- Event
- Event 74295
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16,870
- Official record key
device-enforcement:Z-2239-2016
Official wording
Reason: Cracks ATEC Canister Lids.
Code information: Lot Number: 20150013 and 20150014
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.
Derived failure modes
-
Unknown
Cracks ATEC Canister Lids.