HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
FDA Recall Z-1654-2013 · Posted 2013-07-02
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Recalling FirmClorox Healthcare Holdings, LLC (dba HealthLink)
Recall StatusTerminated
Product CodeLRY
Date Initiated2013-03-18
Date Terminated2014-02-25
Product Quantity1,044,600 units
Reason for Recall
Due to lack of sterilization.
Firm Action
On March 19, 2013, HealthLink sent their customers letters instructing them to do the following: 1) Screen their inventory and quarantine the product. 2) Notify all customers that received the affected products and ask them to return the lots to their firm. 3) Complete the attached form and return the lots to HealthLink Distribution center. For further assistance, customers were directed to call customer service at 1-800-638-2625.
Root Cause
Packaging change control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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