FDA Recall
Terminated
Cook Esophageal Dilator Set --------------------------------------Small label applied by OEM supplier: C CEDS 58 70 * Use By 2008/04 * Lot No. F1734513 * Sterile * Rx only * Cook *** Large product label applied at Cook Endoscopy: Cook Esophageal Dilator Set * Catheter Diameter: 20 FR. Catheter Length: 15cm. * Dilator Diameter: 58 FR. * Dilator Length: 70 CM. * Disposable Single Use Only * Rx Only * 2008/05 * Cook * Wilson Cook Medical GI Endoscopy * 4900 Bethania Station Road, Winston Salem, NC 27105
Recall: Z-0848-06
·
Initiated April 20, 2006
Recall
- Recall Number
- Z-0848-06
- Event Number
- 35265
- Firm
- Cook Endoscopy
- FEI Number
- 1037905
- Product Code
- KOG
- Status
- Terminated
- Root Cause
- Labeling False and Misleading
- Initiated
- April 20, 2006
- Posted
- May 6, 2006
- Terminated
- June 29, 2006
- Address
- 5951 Grassy Creek Blvd, Winston Salem, NC, 27105-1206
Description
Cook Esophageal Dilator Set --------------------------------------Small label applied by OEM supplier: C CEDS 58 70 * Use By 2008/04 * Lot No. F1734513 * Sterile * Rx only * Cook *** Large product label applied at Cook Endoscopy: Cook Esophageal Dilator Set * Catheter Diameter: 20 FR. Catheter Length: 15cm. * Dilator Diameter: 58 FR. * Dilator Length: 70 CM. * Disposable Single Use Only * Rx Only * 2008/05 * Cook * Wilson Cook Medical GI Endoscopy * 4900 Bethania Station Road, Winston Salem, NC 27105
Reason
Large product label contains an incorrect expiration date.
Action
Consignees were notified by letter (USPS certified)on/about April 21, 2006.
Distribution
Alabama consignees
Quantity
43 units