FDAClass IIOctober 29, 2014

DeRoyal(R) SafeLiner Suction Canister Kit recall

DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general hospital

Why was DeRoyal(R) SafeLiner Suction Canister Kit recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 364817213

Product
DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general hospital
Recalling firm
DeRoyal Industries Inc
Quantity
5112 units
Distribution
Nationwide Distribution including MI, OH, IN, FL, WV, VA, MI, NC, and NY
Recall date
October 29, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls