Piston Syringe, 10 CC L/L, 100 per box, 12 boxes/case, 1,200/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

Reason: Insufficient documentation to support product sterility claims.

Code information: Catalog No. SY35010LL. Known Lot No. ("x" represents any release number): 12-6780-x, 12-6925-x, 12-6968-x, 12-7060-x, 12-7119-x, 12-7144-x, 12-7177-x, 12-7208-x, 12-7258-x, 12-7259-x, 12-7324-x, 12-7325-x, 12-7363-x, 12-7391-x, 12-7412-x, 12-7463-x, 12-7469-x, 12-7472-x, 12-7499-x, 13-6780-x, 13-7538-x, 13-7560-x, 13-7581-x, 13-7648-x, 13-7667-x, 13-7702-x, 13-7704-x, 13-7719-x, 13-7733-x, 13-7761-x, 13-7841-x, 13-7920-x, 13-7950-x, 13-7966-x, 13-7988-x, 13-8006-x, 13-8032-x, 13-8039-x, 13-8082-x, 13-8083-x, 13-8084-x, 13-8143-x, 13-8144-x, 13-8145-x, 13-8149-x, 13-8184-x, 13-8185-x, 13-8489-x, 13-8272-x, 14-8327-x, 14-8335-x, 14-8354-x, 14-8385-x, 14-8386-x, 14-8396-x, 14-8440-x, 14-8441-x, 14-8442-x, 14-8457-x, 14-8509-x, 14-8512-x, 14-8513-x, 14-8540-x, 14-8541-x, 14-8542-x, 14-8583-x, 14-8628-x, 14-8631-x, 14-8696-x, 14-8737-x, 14-8794-x, 14-8807-x, 14-8829-x, 14-8863-x, 14-9851-x, 14-9015-x, 14-9035-x, 14-9064-x, 14-9081-x, 15-0113-x, 15-9333-x, 15-9350-x, 15-9351-x, 15-9364-x, 15-9377-x, 15-9442-x, 15-9447-x, 15-9492-x, 15-9550-x, 15-9587-x, 15-9605-x, 15-9630-x, 15-9638-x, 15-9639-x, 15-9716-x, 15-9723-x, 15-9759-x, 15-9797-x, 15-9805-x, 15-9860-x, 15-9873-x, 15-9876-x, 15-9963-x, 16-0366-x, 16-0399-x, 16-0439-x, 16-0441-x, 16-0473-x, 16-0527-x, 16-0624-x, 16-0632-x, 16-0655-x, 16-0736-x, 16-0783-x, 16-0839-x, 16-0904-x, 16-0969-x, 16-1005-x, 16-1023-x, 16-1040-x, 16-1053-x, 16-1054-x, 16-1055-x, 16-1079-x, 16-1101-x, 16-1102-x, 16-1153-x, 16-1165-x, 17-1443-x, 17-1492-x, 17-1527-x, 17-1535-x, 17-1557-x, 17-1562-x, 17-1575-x, 17-1609-x, 17-1613-x, 17-1617-x, 17-1624-x, 17-1637-x, 17-1691-x, 17-1715-x, 17-1791-x.

Distribution pattern: Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.