EZDilate Wire Guided Balloon- Indicated for use in recall: Labeling Error
EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary…
Why was EZDilate Wire Guided Balloon- Indicated for use in recalled?
Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm and may result in prolonged surgery. All other labeling is correct for the balloon, including the Shelf Box with Front Box Label and Circular Star Label and the balloon Pouch
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI-DI: 821925033238 Lot: 408987
- Product
- EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 209 units
- Distribution
- Worldwide Distribution: US distribution to states of: CA, FL, IL, NJ, NY, PA, TN, VA, WI; and Foreign OUS to countries of: CA, DE, IN, SG, Latin America.
- Recall date
- October 30, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)