Recall Z-1234-2017
Custom Medical Specialties, Inc. · initiated September 20, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lots 40629-1609 an 40631-1609
Reason for recall
Sterility of syringe product could not be assured.
FDA-determined 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.
Details
- Recall number
- Z-1234-2017
- Initiated
- September 20, 2016
- Product code
- FCH – Tray, Biopsy, Without Biopsy Instruments
- Quantity
- 80 syringes
- Distribution
- US Distribution to ID and OR.
- Recalling firm
- Custom Medical Specialties, Inc., Pine Level, NC