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Open, Classified

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

FDA Recall Z-1234-2017 · Posted None

Recalling FirmCustom Medical Specialties, Inc.
Recall StatusOpen, Classified
Product CodeFCH
Date Initiated2016-09-20
Product Quantity80 syringes

Reason for Recall

Sterility of syringe product could not be assured.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Distribution to ID and OR.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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