Recall Z-1655-2013 ยท LRY Punch, Surgical
Clorox Healthcare Holdings, LLC (dba HealthLink)
PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
| Date | Jul 2, 2013 (initiated Mar 18, 2013) |
| Status | Terminated |
| Reason | Due to lack of sterilization. |
| Root cause | Packaging change control |
| 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. |
| Quantity | 1,032,700 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, Mexico, and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K921822 | FRAY BIO-PUNCH Fray Products Corp., Oct 28, 1992 |