Cook Polyvinyl Alcohol Foam (PVA ) Embolization Particles, particle size 47-90 microns, 1 cc; order number PVA-50.
FDA device recall Z-1054-03 · posted 2003-07-29 · Terminated
Recall details
- Recalling firm
- Cook, Inc.
- Reason for recall
- Bottle contains less product than is declared on the label.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 56
- Distribution
- United States, Australia, Brazil, Canada, Denmark, Hong Kong, India, Israel, Japan and Taiwan.
- Date initiated
- 2003-07-01
- Date posted
- 2003-07-29
- Date terminated
- 2003-11-13
- Location
- Bloomington, IN
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