Epsilon Skin Tensioner:Rx recall
Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma; Product Usage: Skin Tensioner is applied to patients…
Why was Epsilon Skin Tensioner:Rx recalled?
Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified as a compound of iron and chlorine.
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?
Model number FP-45384
- Product
- Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma; Product Usage: Skin Tensioner is applied to patients…
- Recalling firm
- Restoration Robotics
- Quantity
- 515 in US. 315 International.(included all packaging configurations)
- Distribution
- Worldwide Distribution - USA Nationwide in the countries of: Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan.
- Recall date
- November 27, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)