Device product
DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general hospital
Z-0098-2015
Product summary
- Event
- Event 69319
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5112 units
- Official record key
device-enforcement:Z-0098-2015
Official wording
Reason: These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition.
Code information: Lot 364817213
Distribution pattern: Nationwide Distribution including MI, OH, IN, FL, WV, VA, MI, NC, and NY
Derived failure modes
-
Unknown
These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition.