—#94232

Product

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 product code: KDQ — Bottle, Collection, Vacuum
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Lot Number 22622679

Why it was recalled

Suction canisters may crack during use

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2010-07-01
Posted by FDA: 2010-10-20
Terminated: 2012-04-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94232. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.