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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

FDA Recall Z-0848-06 · Posted 2006-05-06

Recalling FirmCook Endoscopy
Recall StatusTerminated
Product CodeKOG
Date Initiated2006-04-20
Date Terminated2006-06-29
Product Quantity43 units

Reason for Recall

Large product label contains an incorrect expiration date.

Firm Action

Consignees were notified by letter (USPS certified)on/about April 21, 2006.

Root Cause

Labeling False and Misleading

Distribution Pattern

Alabama consignees

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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