Cook Urological, Inc. Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal access, .038", 145 cm; sterile; Order/Ref number 638413. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal access, .038", 145 cm; sterile; Order/Ref number 638413.
Brand
Cook Urological, Inc.
Lot Codes / Batch Numbers
Lot U1621121
Products Sold
Lot U1621121
Cook Urological, Inc. is recalling Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal access, .038", due to Lack of assurance of sterility, in that the product is labeled as sterile but the package may not have been sealed.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of assurance of sterility, in that the product is labeled as sterile but the package may not have been sealed.
Recommended Action
Per FDA guidance
Consignees were notified via letter dated 6/12/07 and instructed to cease using the product and to inform the firm if they have product to return.
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 noticePage updated: Jan 10, 2026