FDAClass IIMarch 1, 2017

CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray recall: Sterility Concern

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

Why was CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray recalled?

Sterility of syringe product could not be assured.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lots 40629-1609 an 40631-1609

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.
Recalling firm
Custom Medical Specialties, Inc.
Quantity
80 syringes
Distribution
US Distribution to ID and OR.
Recall date
March 1, 2017
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls