Home / Recalls / Custom Medical Specialties, Inc. / Z-1234-2017

Z-1234-2017 Class II Ongoing

Recalled by Custom Medical Specialties, Inc. — Pine Level, NC

FDA device recall Z-1234-2017 was initiated by Custom Medical Specialties, Inc. on September 20, 2016 and is designated Class II. Reason for recall: Sterility of syringe product could not be assured. The recall status is ongoing. Affected quantity: 80 syringes.

Recall Details

Product Type: Devices
Report Date: March 1, 2017
Initiation Date: September 20, 2016
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 80 syringes

Product Description

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

Reason for Recall

Sterility of syringe product could not be assured.

Distribution Pattern

US Distribution to ID and OR.

Code Information

Lots 40629-1609 an 40631-1609

Other recalls by Custom Medical Specialties, Inc.

Z-0974-2014 Class II — 5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Spec (July 12, 2013)
D-1650-2012 Class II — CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, (July 23, 2012)
D-1651-2012 Class II — CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride (July 23, 2012)
D-1649-2012 Class II — Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CM (July 23, 2012)
Z-2349-2012 Class I — CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usage: (September 30, 2011)
Z-2359-2012 Class I — CMS-5284 Custom Myelogram Tray containing 2 oz. bottle PVP Prep Solution Prod (September 30, 2011)
Z-2355-2012 Class I — CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiology (September 30, 2011)
Z-2358-2012 Class I — CMS-4975 HSG Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Us (September 30, 2011)
Z-2354-2012 Class I — CMS-8162-R1 Fox Chase Specials Pack containing 2 oz. bottle PVP Prep Solution (September 30, 2011)
Z-2357-2012 Class I — CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 o (September 30, 2011)