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
Product summary
- 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
particulate