FDAFDA · Food and drugs·Recall number Z-2855-2017
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.
Published August 16, 2017 · Recall initiated: June 23, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Insufficient documentation to support product sterility claims.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- International Medsurg Connection, Inc.
- Distributor
- 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.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.