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U.S. Department of Health and Human Services

Class 2 Device Recall VisuaLine Single Dip Oxycodone

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 Class 2 Device Recall VisuaLine Single Dip Oxycodonesee related information
Date Initiated by FirmMay 28, 2008
Date PostedSeptember 17, 2008
Recall Status1 Terminated 3 on June 10, 2009
Recall NumberZ-1873-2008
Recall Event ID 48464
Product Classification Methadone enzyme immunoassay - Product Code DJR
ProductVisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.
Code Information Sun Biomedical Part Numbers: 15-2016; Product lot number Vis-OXD-dip 07-018-1-275 or Vis OXD-Dip 07-081-257. 
Recalling Firm/
Manufacturer
Sun Biomedical Laboratories, Inc.
1001 Lower Landing Rd
Blackwood NJ 08012-3124
For Additional Information ContactM. Jack Kerins
856-401-1080
Manufacturer Reason
for Recall
Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied.
FDA Determined
Cause 2
Other
ActionOn May 29, 2008, Recall Notification Letters were sent via UPS Ground. Each letter had a red label reading "Market Withdrawal Notification on the envelope. Use of the product and distribution was to stop immediately. Returns to be made by UPS and replacement or refund to be issues. If you have any questions contact Jenny Shelton, Sun Biomedical, at 1-888-440-8388.
Quantity in Commerce330 kits of product VIX-OXD-Dip 07-081-1-257; 1 kits of Vix-OXD-07-018-275
DistributionClass II Recall - Nationwide Distribution --- including states of NJ, TN, LA, GA, AZ, PA, NE, OH, ME, DE, VA, and CT.
Total Product Life CycleTPLC 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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