Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G14191; Catalog No. 073710.
This recall has been terminated (originally issued September 24, 2005).
- Company
- Cook Urological, Inc.
- Recall Initiated
- August 1, 2005
- Posted
- September 24, 2005
- Terminated
- October 26, 2005
- Recall Number
- Z-1584-05
- Quantity
- 3
- Firm Location
- Spencer, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Mislabeled as to size.
Distribution
California and Florida.
Lot / Code Info
Lots 15-U1320351 and 15-U1320349.
Root Cause
Other
Action Taken
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.
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