ClearanceBrief
Recall Z-0101-2011 ยท KDQ Bottle, Collection, Vacuum

DeRoyal Industries Inc

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.

DateOct 20, 2010 (initiated Jul 1, 2010)
StatusTerminated
ReasonSuction canisters may crack during use
Root causeOther
ActionDeRoyal 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 vi
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.