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Recall Observatory FDA recall evidence

Device product

Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, SEMI-RIGID, Cat. No. V71-6510, NON-STERILE, Rx Only general hospital

Z-0097-2015

August 22, 2014

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 69319
Status
Terminated
Classification
Class II
Quantity
13,900 units
Official record key
device-enforcement:Z-0097-2015

Official wording

Reason: These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition.

Code information: 1) DeRoyal(R), REF 71-6510, Lot 36408631 2) NOVAPLUS(TM) Cat. No. V71-6510, Lot 36408622

Distribution pattern: Nationwide Distribution including MI, OH, IN, FL, WV, VA, MI, NC, and NY

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition.