FDA-Device2015-09-30Class II
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
Zien Medical Technologies, Inc
Hazard
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.
Sold states
Worldwide distribution to U.S. nationwide, Germany and England.
Affected count
28,284
Manufactured in
2500 S State St, Sted240, Salt Lake City, UT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2800-2015Don't want to check this manually?
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