Recall Z-0848-06 ยท KOG
Cook Endoscopy
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
| Date | May 6, 2006 (initiated Apr 20, 2006) |
| Status | Terminated |
| Reason | Large product label contains an incorrect expiration date. |
| Root cause | Labeling False and Misleading |
| Action | Consignees were notified by letter (USPS certified)on/about April 21, 2006. |
| Quantity | 43 units |
| Distribution | Alabama consignees |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.