Home / Recalls / International Medsurg Connection, Inc. / Z-2831-2017

Z-2831-2017 Class II Terminated

Recalled by International Medsurg Connection, Inc. — Schaumburg, IL

Recall Details

Product Type
Devices
Report Date
August 16, 2017
Initiation Date
June 23, 2017
Termination Date
August 24, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
54,204,100 units total

Product Description

Piston Syringe and Hypodermic Needle, 3 CC L/L 21 G X 1.5, 100 per box, 24 boxes/case, 2,400/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 for Recall

Insufficient documentation to support product sterility claims.

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.

Code Information

Catalog No. SN0032115. 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.

Other recalls by International Medsurg Connection, Inc.

  • Z-2813-2017 Class II — Hypodermic Needle, 21 G X 1.5 in YALE DISP, 100 per box, 50 boxes/case, 5,000/ca (June 23, 2017)
  • Z-2805-2017 Class II — Hypodermic Needle, 16G X 1.5in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,000/ (June 23, 2017)
  • Z-2851-2017 Class II — Piston Syringe, 3 CC L/L, 100 per box, 30 boxes/case, 3,000/case The products (June 23, 2017)
  • Z-2830-2017 Class II — Piston Syringe and Hypodermic Needle, 3 CC L/L 21 G X 1.0, 100 per box, 24 boxes (June 23, 2017)
  • Z-2854-2017 Class II — Piston Syringe, 5 CC L/S, 100 per box, 20 boxes/case, 2,000/case The products a (June 23, 2017)
  • Z-2856-2017 Class II — Piston Syringe, 10 CC L/S, 100 per box, 12 boxes/case, 1,200/case The product (June 23, 2017)
  • Z-2842-2017 Class II — Piston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.0, 100 per box, 15 boxes (June 23, 2017)
  • Z-2862-2017 Class II — Piston Syringe, 60 CC L/S, 50 per box, 8 boxes/case, 400/case The products ar (June 23, 2017)
  • Z-2822-2017 Class II — Hypodermic Needle, 27 G X 1.5 in HYPODERMIC, 100 per box, 50 boxes/case, 5,000/c (June 23, 2017)
  • Z-2858-2017 Class II — Piston Syringe, 20 CC L/S, 100 per box, 9 boxes/case, 900/case The products a (June 23, 2017)