FDA Medical Device Recalls (openFDA)
Custom Medical Specialties, Inc.: CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.
- Recall number
- Z-1234-2017
- Recalling firm
- Custom Medical Specialties, Inc.
- 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.
- Status
- Open, Classified
- Initiated
- 2016-09-20
- Posted
- not on file
- Terminated
- not on file
- Reason
- Sterility of syringe product could not be assured.
- Root cause
- 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
- 80 syringes
- Distribution
- US Distribution to ID and OR.
- Lot, serial or model codes
- Lots 40629-1609 an 40631-1609
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FCH
- Firm FEI
- 3005474845
- Firm city
- Pine Level
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28