Cook, Inc. Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 22 mm - iliac leg diameters 11 mm - main body lengths cntralateral limb 103mm ipsilateral limb 133 mm - delivery system 18 FR; Catalog no. TFB-22-103 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 22 mm - iliac leg diameters 11 mm - main body lengths cntralateral limb 103mm ipsilateral limb 133 mm - delivery system 18 FR; Catalog no. TFB-22-103
Brand
Cook, Inc.
Lot Codes / Batch Numbers
Lots 1351975, F1563256, F1576435 and 1349754.
Products Sold
Lots 1351975, F1563256, F1576435 and 1349754.
Cook, Inc. is recalling Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloade due to Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer durin. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
Recommended Action
Per FDA guidance
The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.
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