| Class 3 Device Recall | |
Date Initiated by Firm | April 20, 2006 |
Date Posted | May 06, 2006 |
Recall Status1 |
Terminated 3 on June 29, 2006 |
Recall Number | Z-0848-06 |
Recall Event ID |
35265 |
Product Classification |
unknown device name - Product Code KOG
|
Product | 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 |
Code Information |
Lot: W2110292, Correct expiration on Small OEM Label: Mar-08, Expiration date on Large Label Apr-08; W2118663, Correct exp.: Mar-08, Exp. On large label: Apr-08; W2126166, Correct exp.: Apr-08, Exp. On large label: May-08; W2128638, Correct exp.: Apr-08, Exp. On large label: May-08; W2128639, Correct exp.: Apr-08, Exp. On large label: May-08; W2138018, Correct exp.: Apr-08, Exp. On large label: May-08; W2143643, Correct exp.: Apr-08, Exp. On large label: May-08; W2150003, Correct exp.: Apr-08, Exp. On large label: May-08; W2177983, Correct exp.: Apr-08, Exp. On large label: May-08; W2190096, Correct exp.: Sep-08, Exp. On large label: Oct-08; W2194318, Correct exp.: Sep-08, Exp. On large label: Oct-08. |
Recalling Firm/ Manufacturer |
Cook Endoscopy 5951 Grassy Creek Blvd Winston Salem NC 27105-1206
|
For Additional Information Contact | Sharon Miles 336-767-2657 Ext. 6325 |
Manufacturer Reason for Recall | Large product label contains an incorrect expiration date. |
FDA Determined Cause 2 | Labeling False and Misleading |
Action | Consignees were notified by letter (USPS certified)on/about April 21, 2006. |
Quantity in Commerce | 43 units |
Distribution | Alabama consignees |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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