NOVAPLUS (TM), SUCTION CANISTER, 1200cc, RIGID, WITH ELBOW, Cat. No. V71-3001, Rx only, NON-STERILE, Made exclusively for Novation by DeRoyal, 200 DeBusk Lane, Powell, TN 37849 Most commonly used during medical medical emergencies and surgery to remove fluid and secretions from a patient.
FDA Recall Z-0101-2011 · Posted 2010-10-20
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Recalling FirmDeRoyal Industries Inc
Recall StatusTerminated
Product CodeKDQ
Date Initiated2010-07-01
Date Terminated2012-04-10
Reason for Recall
Suction canisters may crack during use
Firm Action
DeRoyal sent a Recall letter dated July 1, 2010 to all their consignees via UPS Air. The letter identified the product, the problem, and action to be taken by the consignees.
Consignees were to complete the Recall Response Form by checking their inventory for DeRoyal Suction Canisters V71-3001, Lot #22622679.
Indicate the number of replacement products needed on the Recall Response Form, including the address, reference PO#, etc. to be used for the replacement products and fax the form to DeRoyal at 865-362-3755 no later than July 7, 2010.
Recalled products were to be returned to DeRoyal via UPS Ground
Attn: Quality Control
300 DeBusk Lane
Powell, TN 37849
Once the recalled product was received by DeRoyal, the replacement product would be shipped per the instructions on the Recall Response Form.
Distributors were to forward the recall notice to their end-users, or provide customer listing so that DeRoyal may contact them.
For any questions or assistance regarding this recall call 865-362-1037.
Root Cause
Other
Distribution Pattern
Nationwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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