216 Wilson Frame Pads recall
216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads…
Why was 216 Wilson Frame Pads recalled?
Mizuho has discovered that the 5319-37 Wilson Frame Pads have a design deficiency in the construction of their mounting sleeves that may allow the patient to contact the underlying carbon fiber structure of the Wilson frame and could lead to a pressure injury.
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?
All Lots: Manufacturing dates: December 2016 through March 2017; GTIN:00842430100192
- Product
- 216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads…
- Recalling firm
- Mizuho OSI
- Quantity
- 216 sets
- Distribution
- United States, Canada, Japan, Australia, New Zealand, Great Britain, Sweden, Spain, Germany, Switzerland, Kenya, Saudi Arabia, Hong Kong, South Korea.
- Recall date
- April 26, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)