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U.S. Department of Health and Human Services

Class 2 Device Recall MicroMate Tuberculin Glass Syringe

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  Class 2 Device Recall MicroMate Tuberculin Glass Syringe see related information
Date Initiated by Firm July 09, 2015
Date Posted August 10, 2015
Recall Status1 Terminated 3 on July 29, 2016
Recall Number Z-2365-2015
Recall Event ID 71674
Product Classification Needle, aspiration and injection, disposable - Product Code GAA
Product Micro-Mate Tuberculin Glass Syringe, Non-sterile
Catalog numbers 5208, 5209
Code Information Packged Lots:  Catalog Number 5208: 79895-01, 80044-02, 82350-01, W006510/1;  Catalog Number 5209: 71880-01, 76434-01, 76461-01, 76461-02, 76461-03, 76461-04, 76461-05, 76461-06, 76461-07, 76461-08, 79748-01, 80044-03, W001711/1, W002337/1, W002886/1
Recalling Firm/
Manufacturer		 Cadence Inc.
2080 Plainfield Pike
Cranston RI 02921-2012
For Additional Information Contact SAME
401-942-1031
Manufacturer Reason
for Recall		 Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel.
FDA Determined
Cause 2		 Device Design
Action Cadence issued the recall letter, specific to the customer dated 7/9/15 via registered mail on July 17, 2015. Accounts are requested to Recalled products must not be used. 2. Locate and quarantine all affected products. 3. Contact Cadence Science, Inc. using the Response Form provided. 4. If this information is received by a dealer, wholesaler, or distributor/reseller that distributed any of these products to other facilities, then notify their customers of this action so that those customers can locate and remove all affected products. Any questions contact: Phone: 401-942-1031
Quantity in Commerce 1665 units
Distribution Nationwide Foreign Canada, Denmark. Italy
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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