FDA recall Z-2827-2017

International Medsurg Connection, Inc. · Class II · device

Product

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

Reason for recall

Insufficient documentation to support product sterility claims.

Distribution

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.

Key facts

Status
Terminated
Initiation date
2017-06-23
Report date
2017-08-16
Termination date
2020-08-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Schaumburg, IL, United States

Primary source

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