Cook, Inc. Cook brand Zenith rupture main body graft, preloaded graft measuring 22 mm diameter at promial end and 12 mm diameter at distal end, with the H&L-B One Shot Introducer System, non-sterile, export only for further processing; ZRB-22-WCE. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cook brand Zenith rupture main body graft, preloaded graft measuring 22 mm diameter at promial end and 12 mm diameter at distal end, with the H&L-B One Shot Introducer System, non-sterile, export only for further processing; ZRB-22-WCE.
Brand
Cook, Inc.
Lot Codes / Batch Numbers
Lots F1544275, F1544271, F1544272, F1544273, F1544274, F1554507, F1554509, F1554510, F1554511, F1554512, F1554513 and F1554514.
Products Sold
Lots F1544275, F1544271, F1544272, F1544273, F1544274, F1554507, F1554509, F1554510, F1554511, F1554512, F1554513 and F1554514.
Cook, Inc. is recalling Cook brand Zenith rupture main body graft, preloaded graft measuring 22 mm diameter at promial end a 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