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U.S. Department of Health and Human Services

Class 2 Device Recall PenBlade Safety Scalpel

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  Class 2 Device Recall PenBlade Safety Scalpel see related information
Date Initiated by Firm August 18, 2015
Date Posted September 21, 2015
Recall Status1 Terminated 3 on December 09, 2015
Recall Number Z-2800-2015
Recall Event ID 72038
Product Classification Scalpel, one-piece - Product Code GDX
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
Code Information Product Code PB-M-10, Lots 140901J-A, 150228PB10, 150509PB10, 150510PB10; Product Code PB-M-11P, Lots 140901J-B, 150227PB11, 150318PB11, 150509PB11, 150510PB11; Product Code PB-M-15, Lots 140901J-C, 150226PB15, 150326PB15, 150511PB15, 150512PB15, 150529PB15.
Recalling Firm/
Manufacturer		 Zien Medical Technologies, Inc
2500 S State St
Sted240
Salt Lake City UT 84115-3110
Manufacturer 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.
FDA Determined
Cause 2		 Packaging process control
Action All consignees have been notified via email with an attached copy of the recall letter. Telephone calls with be made to all customers and distributors that do not respond directly to email notification to ensure compliance to the recall.
Quantity in Commerce 28,284
Distribution Worldwide distribution to U.S. nationwide, Germany and England.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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