Terumo AZUR Peripheral Coil System recall
Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and 45-680820, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
Why was Terumo AZUR Peripheral Coil System recalled?
The devices may be missing the implant coil.
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?
Catalog/lot numbers: 45-681026 - 1903085J5,1903155J5, and 1904035J5; 45-681434 - 1903015J5,1903155J5, and 1904155J5; 45-682050 - 1903085K5, 1903135J5, 1903155J5, 1904015J5, 1904155J5, 1904175J5, and 1905105K5; and 45-680820 - 1903045J5, 1903085K5, 1903155J5, 1904015J5, 1904035J5, and 1904155J5.
- Product
- Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and 45-680820, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
- Recalling firm
- Microvention, Inc.
- Quantity
- 107 units
- Distribution
- The devices were distributed to Maryland. There was no direct military/government distribution. Foreign distribution was made direct to Belgium, Japan, Australia, Argentina, and Mexico.
- Recall date
- February 19, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)