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.…

Recall date

August 18, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2800-2015

FDA classification

Class II

Brand / firm

Zien Medical Technologies, Inc

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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