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Custom Medical Specialties, Inc.

CUSTOM ASSEMBLIES, INC. · Model CMS-6079 · UDI-DI 00815849021914

KDT
10
510(k) clearances
287
Adverse events
17
Recalls
113
Facilities

Description

Specimen Tube - Sterile

Recalls

DateFirmReason
2011-01-09Heritage Labs International LLCKits contain recalled Triad alcohol pads
2011-01-09Heritage Labs International LLCKits contain recalled Triad alcohol pads
2011-01-09Heritage Labs International LLCKits contain recalled Triad alcohol pads
2011-01-09Heritage Labs International LLCKits contain recalled Triad alcohol pads
2011-01-09Heritage Labs International LLCKits contain recalled Triad alcohol pads
2011-01-09Heritage Labs International LLCKits contain recalled Triad alcohol pads
2011-01-09Heritage Labs International LLCKits contain recalled Triad alcohol pads
2011-01-09Heritage Labs International LLCKits contain recalled Triad alcohol pads
2011-01-09Heritage Labs International LLCKits contain recalled Triad alcohol pads
2011-01-09Heritage Labs International LLCKits contain recalled Triad alcohol pads

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.