TERUMO HydroPearl Compressible Microspheres for recall
TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Why was TERUMO HydroPearl Compressible Microspheres for recalled?
Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
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?
Model/Catalog Number: HP2S0600 UDI Code: (01)00816777026118(11)230710(17)260630(10)0000342047 Lot Number: 0000342047
- Product
- TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
- Recalling firm
- MICROVENTION INC.
- Quantity
- 22 units
- Distribution
- U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI.
- Recall date
- February 7, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)