Z-1492-2009

Arrow ARROWg+ard Super Arrow-Flex Percutaneous Sheath Introducers

Name: Z-1492-2009 Arrow ARROWg+ard Super Arrow-Flex Percutaneous Sheath Introducers
Creator: Arrow International Inc
Published: 2009-02-11
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2009-02-11 / Terminated / root cause: design

FDA source

Arrow International Inc began a recall of Arrow ARROWg+ard Super Arrow-Flex Percutaneous Sheath Introducers on 2009-02-11. The reason FDA records is "Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1492-2009
Status: Terminated
Initiated: 2009-02-11
Posted: 2009-06-24
Terminated: 2010-07-22
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow ARROWg+ard Super Arrow-Flex Percutaneous Sheath Introducers
Product code: DYB Introducer, Catheter
Reason for recall: Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.
Root cause tag: design
FDA root cause: Device Design
Action: Arrow International issued a letter dated 2/18/09 to all customers informing them of the problem and if a lipid resistant stopcock is required to contact the firm for replacements. New labels state: Warning - do not use with lipid containing solutions or 70% isopropyl alcohol, as these solutions may cause leakage or air embolism.
Quantity in commerce: 900,000 total, all products
Distribution: Worldwide distribution: USA, Argentina, Australia, Bahamas, Belarus, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Singapore, Slovakia, South Africa, South Korea, Spain, Sri lanka, Sweden, Taiwan, Thailand, Tunisia, Turkey, UK, Ukraine, and Venezuela.
Product codes and lots: All lots of Product codes listed in Z-1489-2009.

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)