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.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 1
100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.
On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it was rejected by Steris due to failing process indicators.
These labels are deterministic app interpretations, not FDA categories.
On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it was rejected by Steris due to failing process indicators.
Code information
Product code KCT; Lot number: 60263
Distribution pattern
Worldwide Distribution--USA (nationwide) including the states of AL, AZ, CA, FL, IL, IN, KY, LA, MO, MS, NJ, OH, PA, SD, TX, and VA., and the countries of Japan, Peru, and Suriname.
