Home / Recalls / International Medsurg Connection, Inc. / Z-2817-2017

Z-2817-2017 Class II Terminated

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

FDA device recall Z-2817-2017 was initiated by International Medsurg Connection, Inc. on Jun 23, 2017 and is designated Class II. Reason for recall: Insufficient documentation to support product sterility claims. The recall status is terminated (terminated Aug 24, 2020). Affected quantity: 54,204,100 units total.

Recall Details

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

Product Description

Hypodermic Needle, 25 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/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. N3602510. 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.

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2817-2017
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by International Medsurg Connection, Inc.

  • Z-2805-2017 Class II — Hypodermic Needle, 16G X 1.5in DSP REG BEVEL, 100 per box, 50 boxes/case… (Jun 23, 2017)
  • Z-2851-2017 Class II — Piston Syringe, 3 CC L/L, 100 per box, 30 boxes/case, 3,000/case The products… (Jun 23, 2017)
  • Z-2857-2017 Class II — Piston Syringe, 20 CC L/L, 100 per box, 9 boxes/case, 900/case The products… (Jun 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… (Jun 23, 2017)
  • Z-2854-2017 Class II — Piston Syringe, 5 CC L/S, 100 per box, 20 boxes/case, 2,000/case The products… (Jun 23, 2017)
  • Z-2856-2017 Class II — Piston Syringe, 10 CC L/S, 100 per box, 12 boxes/case, 1,200/case The… (Jun 23, 2017)
  • Z-2846-2017 Class II — Piston Syringe and Hypodermic Needle, 10 CC L/L 21 G X 1.0, 100 per box, 10… (Jun 23, 2017)
  • Z-2822-2017 Class II — Hypodermic Needle, 27 G X 1.5 in HYPODERMIC, 100 per box, 50 boxes/case… (Jun 23, 2017)
  • Z-2836-201 Class II — Piston Syringe and Hypodermic Needle, 3 CC L/L 25 G X 1.0, 100 per box, 24… (Jun 23, 2017)
  • Z-2813-2017 Class II — Hypodermic Needle, 21 G X 1.5 in YALE DISP, 100 per box, 50 boxes/case… (Jun 23, 2017)

FDA data resources