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Recall Observatory FDA recall evidence

Device product

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

Z-3059-2017

June 15, 2017

Class II

Product summary

Firm
Custom Assemblies Inc
Event
Event 77962
Status
Terminated
Classification
Class II
Quantity
2155 kits
Official record key
device-enforcement:Z-3059-2017

Official wording

Reason: 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.

Code information: (a) Lot Numbers: 42754-1603, 42798-1603, 43030-1604 (b) Lot Numbers: 42696-1602, 43200-1604, 433322-1605 (c) Lot Numbers: 43056-1604, (d) Lot Numbers: 42836-1603, 43182-1604 (e) Lot Numbers: 42794-1603 (f) Lot Numbers: 42912-1603 (g) Lot Numbers: 43416-1606 (h) Lot Numbers: 43414-1606

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

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    particulate