# FDA recall Z-3059-2017

> **Custom Assemblies Inc** · Class II · device recall initiated 2017-06-15.

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-3059-2017
- **Recalling firm:** Custom Assemblies Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-15
- **Report date:** 2017-08-30
- **Termination date:** 2017-08-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pine Level, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3059-2017

## Citation

> AI Analytics. FDA recall Z-3059-2017. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-3059-2017. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*