Z-1234-2017Class II

CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS...

Name: Z-1234-2017 CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS...
Creator: Custom Medical Specialties, Inc.
Published: 2016-09-20
License: https://open.fda.gov/license/

Custom Medical Specialties, Inc. / initiated 2016-09-20 / Open, Classified / root cause: manufacturing process

FDA source

Custom Medical Specialties, Inc. began a recall of CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc on 2016-09-20. FDA classified it as Class II and gives the reason as "Sterility of syringe product could not be assured". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1234-2017
Classification: Class II
Status: Open, Classified
Initiated: 2016-09-20
Posted: 2017-02-22
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.
Product code: FCH Tray, Biopsy, Without Biopsy Instruments
Reason for recall: Sterility of syringe product could not be assured.
Root cause tag: manufacturing process
FDA 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 in commerce: 80 syringes
Distribution: US Distribution to ID and OR.
Product codes and lots: Lots 40629-1609 an 40631-1609

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1234-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1234-2017	Class II	Ongoing	Voluntary: Firm initiated	2017-03-01	2017-02-22

Product code FCH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)