Microvention recall: Sterility Concern
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
Why was Microvention recalled?
Sterility assurance; microcatheter inner packaging may contain incomplete seal.
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?
Lot # 0000629846/UDI: (01)00816777027634
- Product
- Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
- Recalling firm
- MICROVENTION INC.
- Quantity
- 107 units
- Distribution
- US: None OUS: China
- Recall date
- January 29, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)