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U.S. Department of Health and Human Services

Class 3 Device Recall Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or NonVacuum ESR Tubes

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  Class 3 Device Recall Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or NonVacuum ESR Tubes see related information
Date Initiated by Firm April 12, 2010
Date Posted June 22, 2010
Recall Status1 Terminated 3 on September 13, 2010
Recall Number Z-1816-2010
Recall Event ID 55535
Product Classification Tube, sedimentation rate - Product Code GHC
Product Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or Non-Vacuum ESR Tubes. Single Use. Product Number: EX-I0552. Manufactured by Vital Diagnostics S.R.L., Italy.

Slider allows a larger label to be applied to the ESR tube.
Code Information All Lot Numbers
Recalling Firm/
Manufacturer		 Vital Diagnostics, Inc.
27 Wellington Rd
Lincoln RI 02865-4411
For Additional Information Contact SAME
401-642-8400
Manufacturer Reason
for Recall		 The tube may fall out or separate from the Slider adapter
FDA Determined
Cause 2		 Component change control
Action Vital Diagnostics issued recall letter dated April 14, 2010 via Certified Mail in an envelop marked "Urgent Recall Information Inside", requesting accounts to discontinue use and destroy recalled product. A Certificate of Destruction and Refund Form was included to direct customers. A second Distributor Notice was sent by email to the distributors with Important Recall Information in the title. This was accompanied with the same Technical Bulletin, Certificate of Destruction and Refund Form. For further information, contact Vital Diagnostics at 1-800-345-2822.
Quantity in Commerce 4,723 units
Distribution Distributed Nationwide and Canada.
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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