Arrow International Inc Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr Catheters. The product is shipped in cases containing 5 catheters (contains Q-Syte) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr Catheters. The product is shipped in cases containing 5 catheters (contains Q-Syte)
Brand
Arrow International Inc
Lot Codes / Batch Numbers
Product number ASK-29803-SJH. Lot numbers RF9044900 and RF9068155
Products Sold
Product number ASK-29803-SJH. Lot numbers RF9044900 and RF9068155
Arrow International Inc is recalling Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath, Integral Hemostasis Valve/Side P due to Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter.
Recommended Action
Per FDA guidance
The recalling firm issued an Urgent Medical Device Recall letter dated 11/24/09 to their customers informing them of the problem the need to return any kits in inventory and notify their customers of the recall. For additional information customers can contact the Customer Service Department at 800-523-8446.
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
GA, IN, MD, VA
Page updated: Jan 10, 2026