Reported Sep 30, 2015 · Terminated
PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr.…
Zien Medical Technologies, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zien Medical Technologies, Inc · 2500 S State St · Salt Lake City, UT · 84115-3110
Is this the product you have?
- 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
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published PB-M-10Lots 140901J-A, 150228PB10, 150509PB10, 150510PB10 PB-M-11PLots 140901J-B, 150227PB11, 150318PB11, 150509PB11, 150510PB11 PB-M-15Lots 140901J-C, 150226PB15, 150326PB15, 150511PB15, 150512PB15, 150529PB15. - Amount recalled
- 28,284
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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