Home / Recalls / Zien Medical Technologies, Inc / Z-2800-2015

Z-2800-2015 Class II Terminated

Recalled by Zien Medical Technologies, Inc — Salt Lake City, UT

Recall Details

Product Type: Devices
Report Date: September 30, 2015
Initiation Date: August 18, 2015
Termination Date: December 9, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 28,284

Product Description

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

Reason for Recall

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.

Distribution Pattern

Worldwide distribution to U.S. nationwide, Germany and England.

Code Information

Product Code PB-M-10, Lots 140901J-A, 150228PB10, 150509PB10, 150510PB10; Product Code PB-M-11P, Lots 140901J-B, 150227PB11, 150318PB11, 150509PB11, 150510PB11; Product Code PB-M-15, Lots 140901J-C, 150226PB15, 150326PB15, 150511PB15, 150512PB15, 150529PB15.