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U.S. Department of Health and Human Services

Class 2 Device Recall NOVAPLUS (TM), SUCTION CANISTER

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  Class 2 Device Recall NOVAPLUS (TM), SUCTION CANISTER see related information
Date Initiated by Firm July 01, 2010
Date Posted October 20, 2010
Recall Status1 Terminated 3 on April 10, 2012
Recall Number Z-0101-2011
Recall Event ID 56682
Product Classification Bottle, collection, vacuum - Product Code KDQ
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.
Code Information Lot Number 22622679
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information Contact Tracy Edmundson
865-362-2334
Manufacturer Reason
for Recall		 Suction canisters may crack during use
FDA Determined
Cause 2		 Other
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.
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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