Medical device recalls Moderate risk

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

Recall date
September 20, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1234-2017
FDA classification
Class II
Brand / firm
Custom Medical Specialties, Inc.
Sold / distributed
US Distribution to ID and OR.

Why it was recalled

Sterility of syringe product could not be assured.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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