Z-3059-2017 Class II Terminated
FDA device recall Z-3059-2017 was initiated by Custom Assemblies Inc on Jun 15, 2017 and is designated Class II. 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 recall status is terminated (terminated Aug 28, 2017). Affected quantity: 2155 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 30, 2017
- Initiation Date
- Jun 15, 2017
- Termination Date
- Aug 28, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2155 kits
Product Description
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 Pattern
Nationwide Distribution to NJ, TN, NY, KS, OH, CA,
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3059-2017
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026