Date Initiated by Firm |
September 20, 2016 |
Create Date |
February 22, 2017 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1234-2017 |
Recall Event ID |
76276 |
Product Classification |
Tray, biopsy, without biopsy instruments - Product Code FCH
|
Product |
CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc. |
Code Information |
Lots 40629-1609 an 40631-1609 |
Recalling Firm/ Manufacturer |
Custom Medical Specialties, Inc. 330 East Main Street Pine Level NC 27568
|
For Additional Information Contact |
Diane McAlinn 919-202-8462 Ext. 205
|
Manufacturer Reason for Recall |
Sterility of syringe product could not be assured.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
A letter was issued to customers on 9/20/2016 notifying them of the recall of the 10 cc syringe by BD. The letter tells them not to use the syringe in the kit, and to use the syringe on the outside of the kit which is not part of the recall. |
Quantity in Commerce |
80 syringes |
Distribution |
US Distribution to ID and OR. |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|