ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
FDA device recall Z-1656-2013 · posted 2013-07-02 · Terminated
Recall details
- Recalling firm
- Clorox Healthcare Holdings, LLC (dba HealthLink)
- Reason for recall
- Due to lack of sterilization.
- Action taken
- 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
- Status
- Terminated
- Product code
- LRY
- Quantity affected
- 772,600 units
- Distribution
- 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,
- Date initiated
- 2013-03-18
- Date posted
- 2013-07-02
- Date terminated
- 2014-02-25
- Location
- Jacksonville, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FRAY BIO-PUNCH (K921822) | Fray Products Corp. | 1992-10-28 |