Recall Z-2800-2015— Zien Medical Technologies, Inc
Class II · Terminated
Class II FDA medical device recall by Zien Medical Technologies, Inc, initiated 2015-08-18, terminated 2015-12-09. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: 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..
- Recalling firm
- Zien Medical Technologies, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-18
- Terminated
- 2015-12-09
- Firm location
- Salt Lake City, UT, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.