Cook Urological, Inc. Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G14191; Catalog No. 073710. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G14191; Catalog No. 073710.
Brand
Cook Urological, Inc.
Lot Codes / Batch Numbers
Lots 15-U1320351 and 15-U1320349.
Products Sold
Lots 15-U1320351 and 15-U1320349.
Cook Urological, Inc. is recalling Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G due to Mislabeled as to size.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeled as to size.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL
Page updated: Jan 10, 2026