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Terminated

Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Custom Safety Mammo Biopsy Tray (c) CMS-4108 Multipurpose Safety Tray (d) CMS-3141-R6 Custom Ultrasound Tray (e) CMS-2891-R1 Custom Safety Biopsy Tray (f) CMS-5798-R1 Custom Safety Biopsy Tray (g) CMS-2357R2 Custom Biopsy Tray (h) CMS-2540-R4 Custom Biopsy Tray

FDA Recall Z-3059-2017 · Posted 2017-08-22

Recalling FirmCustom Assemblies Inc
Recall StatusTerminated
Product CodeLRO
Date Initiated2017-06-15
Date Terminated2017-08-28
Product Quantity2155 kits

Reason for Recall

The firm manufactured and distributed custom surgical kits which contained BD SafetyGlide" 22GA 1 inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection.

Firm Action

BD sent an Urgent Medical Device Recall letter dated June 12, 2017, to all affected consignees. Consignees were instructed to examine their inventory and quarantine any affected product. Consignees with questions should call 201-847-4267. For questions regarding this recall call 919-202-8462.

Root Cause

Material/Component Contamination

Distribution Pattern

Nationwide Distribution to NJ, TN, NY, KS, OH, CA,

Official Source

View FDA Recall →

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

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