PenBlade Safety Scalpel recall: Sterility Concern
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…
Why was PenBlade Safety Scalpel 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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…
- Recalling firm
- Zien Medical Technologies, Inc
- Quantity
- 28,284
- Distribution
- Worldwide distribution to U.S. nationwide, Germany and England.
- Recall date
- September 30, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)