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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77962

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
June 15, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Custom Assemblies Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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
Recall number
Z-3059-2017
Initiated
June 15, 2017
Classification
Class II
Status
Terminated
Recalling firm
Custom Assemblies Inc
Quantity
2155 kits

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
particulate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

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.

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,