Class II — Custom Assemblies Inc
| Recalling firm | CUSTOM ASSEMBLIES, INC. |
|---|---|
| Registered facility | CUSTOM ASSEMBLIES, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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 |
| Quantity | 2155 kits |
| Distribution | Nationwide Distribution to NJ, TN, NY, KS, OH, CA, |
| Initiated | 2017-06-15 |
| Classified | 2017-08-22 |
| Terminated | 2017-08-28 |
| Recall number | Z-3059-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Custom Assemblies Inc (Z-3059-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77962/
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