Cook Urological, Inc. Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL.
Brand
Cook Urological, Inc.
Lot Codes / Batch Numbers
Lot U1546391.
Products Sold
Lot U1546391.
Cook Urological, Inc. is recalling Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL. due to Lack of assurance of sterility, as the packages 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, as the packages may not have been sealed.
Recommended Action
Per FDA guidance
Consignees were notified via recall letter dated 1/5/07 and requested to return the product.
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
ME, MA, NH, PR
Page updated: Jan 10, 2026