FDA-Device2017-08-16Class II

Piston Syringe and Hypodermic Needle, 1 CC TB 28 G X 0.5, 100 per box, 30 boxes/case, 3,000/case

International Medsurg Connection, Inc.
Hazard

Insufficient documentation to support product sterility claims.

Sold states
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.
Affected count
54,204,100 units total
Manufactured in
935 N Plum Grove Rd Ste F, N/A, Schaumburg, IL, United States
Products
Piston Syringe and Hypodermic Needle, 1 CC TB 28 G X 0.5, 100 per box, 30 boxes/case, 3,000/case

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2827-2017

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