Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G14191; Catalog No. 073710.
FDA Recall Z-1584-05 · Posted 2005-09-24
Recalling FirmCook Urological, Inc.
Recall StatusTerminated
Product CodeKOE
Date Initiated2005-08-01
Date Terminated2005-10-26
Product Quantity3
Reason for Recall
Mislabeled as to size.
Firm Action
The firm advised the hospital customers of the recall by phone on 7/6/05 and asked that the products be returned. One customer was sent a UPS call tag for return of the product and the other customer was requested to refuse receipt of their shipment in transit.
Root Cause
Other
Distribution Pattern
California and Florida.
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.