Z-0784-2010

Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath, Integral Hemostasis Valve/Side Port...

Name: Z-0784-2010 Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath, Integral Hemostasis Valve/Side Port...
Creator: Arrow International Inc
Published: 2009-11-24
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2009-11-24 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions... on 2009-11-24. The reason FDA records is "Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0784-2010
Status: Terminated
Initiated: 2009-11-24
Posted: 2010-03-05
Terminated: 2012-01-18
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
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)
Product code: DYB Introducer, Catheter
Reason for recall: Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 65 kits
Distribution: The products were shipped to distributors in GA, MD, and VA.
Product codes and lots: Product number ASK-29803-SJH. Lot numbers RF9044900 and RF9068155

Product code DYB

K940079Class IIArrow Percutaneous Sheath Introducer Kit Ak-07903Arrow Intl., Inc. / cleared 1994-11-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)