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.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
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device · product 1 of 1
Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm To facilitate the introduction of contrast media into the biliary ducts to obtain a cholangiogram during laparoscopic or open cholecystectomy.
Several complaints were received for the metal support tube missing from the cholangiogram catheter.
Code information
Product Code 18400, Lot No. 01A1400037
Distribution pattern
Worldwide Distribution - USA including the states of AL, AZ, AR, CA, CO, FL, IL, LA, ME, MI, MO, NY, OH, OR, TN, TX, VT and WI., and the country of Belgium.