Cook Esophageal Dilator Set --------------------------------------Small label applied by OEM supplier: C CEDS 58 70 * Us
FDA device recall Z-0848-06 · posted 2006-05-06 · Terminated
Recall details
- Recalling firm
- Cook Endoscopy
- Reason for recall
- Large product label contains an incorrect expiration date.
- Action taken
- Consignees were notified by letter (USPS certified)on/about April 21, 2006.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- KOG
- Quantity affected
- 43 units
- Distribution
- Alabama consignees
- Date initiated
- 2006-04-20
- Date posted
- 2006-05-06
- Date terminated
- 2006-06-29
- Location
- Winston Salem, NC
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