FDA Recall
Terminated
Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 710-1000 microns, 1 cc; order number PVA-700.
Recall: Z-1059-03
·
Initiated July 1, 2003
Recall
- Recall Number
- Z-1059-03
- Event Number
- 26631
- Firm
- Cook, Inc.
- FEI Number
- 1820334
- Status
- Terminated
- Root Cause
- Other
- Initiated
- July 1, 2003
- Posted
- July 29, 2003
- Terminated
- November 13, 2003
- Address
- 750 Daniels Way, Bloomington, IN, 47404-9120
Description
Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 710-1000 microns, 1 cc; order number PVA-700.
Reason
Vial contains less product than is declared on the label.
Action
A recall letter dated July 1, 2003 was sent to all customers receiving product during the recall time period asking for a return of the product.
Distribution
United States, Australia, Brazil, Canada, Denmark, Hong Kong, India, Israel, Japan and Taiwan.
Quantity
216