CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.
- Company
- Custom Medical Specialties, Inc.
- Recall Initiated
- September 20, 2016
- Recall Number
- Z-1234-2017
- Quantity
- 80 syringes
- Firm Location
- Pine Level, NC
Reason for Recall
Sterility of syringe product could not be assured.
Distribution
US Distribution to ID and OR.
Lot / Code Info
Lots 40629-1609 an 40631-1609
Root Cause
Nonconforming Material/Component
Action Taken
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.
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