Various custom surgical kits manufactured for CMS — Class II medical device recall Z-3059-2017
Terminated recall by Custom Assemblies Inc, reported 2017-08-30, distributed nationwide. The firm manufactured and distributed custom surgical kits which contained BD SafetyGlide" 22GA 1¿ inch Needle
| Recall number | Z-3059-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Custom Assemblies Inc, Pine Level, NC, United States |
| Recall initiated | 2017-06-15 |
| Classified | 2017-08-22 |
| Reported by FDA | 2017-08-30 |
| Terminated | 2017-08-28 |
| Distributed | Nationwide (US) |
| Quantity | 2,155 kits |
| Reason classes | specification failure |
| Lot numbers | 42696-1602, 42754-1603, 42794-1603, 42798-1603, 42836-1603, 42912-1603, 43030-1604, 43056-1604, 43182-1604, 43200-1604, 433322-1605, 43414-1606, 43416-1606 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3059-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.