Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.

Reason: The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.

Code information: Lot numbers 61508, 61636, 61683, 61753, 61804, 61812, 61813, 61814, 61815, 61862, 61917, 61949, 61991, 62052, 62089, 62134, and 62156

Distribution pattern: Distribution was nationwide, including PR. There was government/military distribution. Foreign distribution was made to Australia, Austria, Belgium, Denmark, Germany, Greece, India, Italy, Japan, Netherlands, New Zealand, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom,