NONE Class II - A situation in which the use of, or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. NONE Class III - A situation in which the use of, or exposure to a violative product is not likely to cause adverse health consequences. Ortho Pharmaceutical Corporation, Biotech Division, Raritan, New Jersey. Firm-initiated recall complete. Nationwide, Japan, Mexico, Switzerland.
Firm estimates none remains on market.
Product failed to maintain stability throughout the approved dating period. Firm-initiated field correction ongoing. Nationwide and international. 7.5 cm sterile. National-Standard Medical Products Company, Gainesville, Florida.