Recall Z-2800-2015 ยท GDX Scalpel, One-Piece
Zien Medical Technologies, Inc
PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15
| Date | Sep 21, 2015 (initiated Aug 18, 2015) |
| Status | Terminated |
| Reason | Cracks were discovered in the PET tray of a small population of sterile product. These cracks create a risk of loss of sterile barrier for the product. Sampling and root cause analysis indicated that the risk could extend throughout the lots manufactured from September 2014-July 2015. This led to the decision to recall the product. |
| Root cause | Packaging process control |
| Action | All consignees have been notified via email with an attached copy of the recall letter. Telephone calls with be made to all customers and distributors that do not respond directly to email notification to ensure compliance to the recall. |
| Quantity | 28,284 |
| Distribution | Worldwide distribution to U.S. nationwide, Germany and England. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.