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Custom Medical Specialties, Inc.
CUSTOM ASSEMBLIES, INC. · Model CMS-7101 · UDI-DI 00815849022072
5
510(k) clearances
756
Adverse events (55 deaths)
1
Recalls
37
Facilities
Description
Custom HSG Catheter - Sterile
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-05-31 | Karl Storz Endoscopy America Inc | Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging may be compromised, and therefore the sterility of the product could be |
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Get your free API keyRead the docsData 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.