Z-1656-2013 Class II Terminated
FDA device recall Z-1656-2013 was initiated by Clorox Healthcare Holdings, LLC (dba HealthLink) on March 18, 2013 and is designated Class II. Reason for recall: Due to lack of sterilization. The recall status is terminated (terminated February 25, 2014). Affected quantity: 772,600 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 10, 2013
- Initiation Date
- March 18, 2013
- Termination Date
- February 25, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 772,600 units
Product Description
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
Reason for Recall
Due to lack of sterilization.
Distribution Pattern
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.
Code Information
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