PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
Enforcement
- Recall Number
- Z-1655-2013
- Event ID
- 64888
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Clorox Healthcare Holdings, LLC (dba HealthLink)
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 10, 2013
- Initiation Date
- March 18, 2013
- Classification Date
- July 2, 2013
- Termination Date
- February 25, 2014
- Address
- 3611 Saint Johns Bluff Rd S Ste 1, Suite 1, Jacksonville, FL, 32224-2679, United States
Description
PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
Due to lack of sterilization.
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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.
1,032,700 units