FDA-Device2013-07-10Class II

ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

Clorox Healthcare Holdings, LLC (dba HealthLink)
Hazard

Due to lack of sterilization.

Sold states
Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AZ, CA, CO, FL, GA, IA, IL, IN, MI, MO, MS, MT, NC, NJ, NY, OH, SC,TX ,VA ,WA, WI, and HI, and the countries of Canada, Mexico, and New Zealand.
Affected count
772,600 units
Manufactured in
3611 Saint Johns Bluff Rd S Ste 1, Suite 1, Jacksonville, FL, United States
Products
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1656-2013

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