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U.S. Department of Health and Human Services

Class 2 Device Recall CMS2193R7 and CMS1911R3 Custom Biopsy Tray

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  Class 2 Device Recall CMS2193R7 and CMS1911R3 Custom Biopsy Tray see related information
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.
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