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Zien Medical Technologies, Inc recalls PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr.
Recalled September 30, 2015 · FDA recall Z-2800-2015 · Zien Medical Technologies
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. · FDA Class II
Units
28,284
Sold at
Worldwide distribution to U.S. nationwide, Germany and England.
Description
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.
Product
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
Manufacturer(s)
Zien Medical Technologies, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →