Cook, Inc. Cook brand Zenith AAA Converter with the H&L-B One-Shot Introducer System, preloaded converter - proximal diameter 24 mm - distal diameter 12 mm - length 80 mm; Reorder no. ESC-24-12-80. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cook brand Zenith AAA Converter with the H&L-B One-Shot Introducer System, preloaded converter - proximal diameter 24 mm - distal diameter 12 mm - length 80 mm; Reorder no. ESC-24-12-80.
Brand
Cook, Inc.
Lot Codes / Batch Numbers
Lots 1356524, 1356532, 1356519, 1356525, 1356523, 1356522 and 1356529.
Products Sold
Lots 1356524, 1356532, 1356519, 1356525, 1356523, 1356522 and 1356529.
Cook, Inc. is recalling Cook brand Zenith AAA Converter with the H&L-B One-Shot Introducer System, preloaded converter - pro 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