|
Class 2 Device Recall |
|
Date Initiated by Firm |
July 09, 2015 |
Date Posted |
August 10, 2015 |
Recall Status1 |
Terminated 3 on July 29, 2016 |
Recall Number |
Z-2364-2015 |
Recall Event ID |
71674 |
Product Classification |
Needle, aspiration and injection, disposable - Product Code GAA
|
Product |
Perfectum Tuberculin Glass Syringe, Non sterile Catalog numbers 5202, 5205, 5212 |
Code Information |
Packged Lots: Catalog Number 5202: 79713-04, 80468-05, W003542/1, W006324/1, W006324/2, W006324/3, W006324/4, W006324/5; Catalog Number 5205: 79748-03; Catalog Number 5212: W008136/1, W008686/1, W011240/1, W010905/1, W012135/1, W014053/1, W015838/1, W011240 |
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 |
766 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.
|
|
|
|