Z-2274-2010

Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr...

Name: Z-2274-2010 Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr...
Creator: Arrow International Inc
Published: 2010-06-07
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2010-06-07 / Terminated / root cause: sterility

FDA source

Arrow International Inc began a recall of Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Catheters; Catalog number AJ-09801 on 2010-06-07. The reason FDA records is "Sterility not assured. The stopcock handle position was inadvertently changed from an open to a closed position, which prevents sterilization of the closed portion of the device. Sterility of the affected product cannot...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2274-2010
Status: Terminated
Initiated: 2010-06-07
Posted: 2010-08-25
Terminated: 2012-09-29
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Catheters; Catalog number AJ-09801
Product code: KGZ Accessories, Catheter
Reason for recall: Sterility not assured. The stopcock handle position was inadvertently changed from an open to a closed position, which prevents sterilization of the closed portion of the device. Sterility of the affected product cannot be guaranteed.
Root cause tag: sterility
FDA root cause: Process change control
Action: June 7, 2010 Notification letter to customer instructed them to return the product to Arrow. Arrow will destroy the returned product.
Quantity in commerce: 3000 kits
Distribution: All affected product was distributed to one foreign consignee: Arrow Japan Ltd.
Product codes and lots: Lot numbers RF0018145, RF0021641, RF9044164, RF9069739, RF9070837, RF9100262

Product code KGZ

K781846Class IAdapter, Catheter SheathArrow Intl., Inc. / cleared 1978-12-12

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)