Arrow International Inc 9 French Super Arrow-Flex Percutaneous Sheath Introducer Kit with Arrowg and Blue Antimicrobial Surface Sheath Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
9 French Super Arrow-Flex Percutaneous Sheath Introducer Kit with Arrowg and Blue Antimicrobial Surface Sheath
Brand
Arrow International Inc
Lot Codes / Batch Numbers
Catalog numbers AK-07903-AG, SI-07903-AG, JM-07903-AG, and CI-07903-AG.
Products Sold
Catalog numbers AK-07903-AG, SI-07903-AG, JM-07903-AG, and CI-07903-AG.
Arrow International Inc is recalling 9 French Super Arrow-Flex Percutaneous Sheath Introducer Kit with Arrowg and Blue Antimicrobial Surf due to separation of sheath. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
separation of sheath
Recommended Action
Per FDA guidance
The recalling firm issued recall letters dated 7/9/03 to their accounts informing them of the problem and the need to return the product. To expedite product removal the recalling firm telephoned the accounts that received the complaint lot.
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