Recall Z-2800-2015
Zien Medical Technologies, Inc · initiated August 18, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: 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.
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: Packaging process control
Action taken
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.
Details
- Recall number
- Z-2800-2015
- Initiated
- August 18, 2015
- Posted by FDA
- September 21, 2015
- Terminated
- December 9, 2015
- Product code
- GDX – Scalpel, One-Piece
- Quantity
- 28,284
- Distribution
- Worldwide distribution to U.S. nationwide, Germany and England.
- Recalling firm
- Zien Medical Technologies, Inc, Salt Lake City, UT