Recall Z-1655-2013— Clorox Healthcare Holdings, LLC (dba HealthLink)

Name: FDA recall Z-1655-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-18

Class II · Terminated

Class II FDA medical device recall by Clorox Healthcare Holdings, LLC (dba HealthLink), initiated 2013-03-18, terminated 2014-02-25. It names one FDA 510(k) clearance: K921822. Product: PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.. Reason: Due to lack of sterilization..

Recalling firm: Clorox Healthcare Holdings, LLC (dba HealthLink)
Classification: Class II
Status: Terminated
Initiated: 2013-03-18
Terminated: 2014-02-25
Firm location: Jacksonville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K921822 — FRAY BIO-PUNCHFray Products Corp.·cleared 1992-10-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.

Reason for recall

Due to lack of sterilization.

Data sourced from openFDA. This site is unofficial and independent of the FDA.