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.
FDA Recall Z-2325-2012 · Posted 2012-09-06
Advertisement
Reason for Recall
Firm Action
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement