SGD-12-70 Savary-Gilliard Dilator - Diameter: 12MM./36 FR. Length: 70 CM Reusable
FDA Recall Z-0441-06 · Posted 2006-01-25
Recalling FirmCook Endoscopy
Recall StatusTerminated
Product CodeKNQ
Date Initiated2006-01-05
Date Terminated2006-04-04
Reason for Recall
The dilator size does not match the label on the product and product packaging.
Firm Action
A recall letter was issued to the consignees on 1/5/06 requesting return of the product. The letter also requested a sub-recall if the product had been further distributed.
Root Cause
Other
Distribution Pattern
Canada and Australia
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.