Z-1538-2010

Percutaneous Sheath Introducer (PSI) Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr...

Name: Z-1538-2010 Percutaneous Sheath Introducer (PSI) Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr...
Creator: Arrow International Inc
Published: 2009-12-15
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2009-12-15 / Terminated / root cause: packaging

FDA source

Arrow International Inc began a recall of Percutaneous Sheath Introducer (PSI) Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters, Arrow International, Inc., 2400 Bernville... on 2009-12-15. The reason FDA records is "Some central venous catheter sets had the incorrect lid stock". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1538-2010
Status: Terminated
Initiated: 2009-12-15
Posted: 2010-05-05
Terminated: 2011-07-29
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Percutaneous Sheath Introducer (PSI) Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605 Permits venous access and catheter introduction to the central circulation.
Product code: KGZ Accessories, Catheter
Reason for recall: Some central venous catheter sets had the incorrect lid stock.
Root cause tag: packaging
FDA root cause: Packaging
Action: Consignees were notified by an Urgent Medical Device Recall letter on/about 12/15/2009. The letter identified the affected product and stated the reason for the recall. Customers were instructed to immediately check their stock and cease use, distribution, and quarantine affected product. They are also to contact Arrow's Customer Service Department at 800-523-8446 for a Return Authorization Number. Customers are to return any affected product along with the Advisory Acknowledgement and Stock Status Form. Arrow will either provide replacement with a similar product or credit customers' accounts. Customer Service can be contacted with questions or for clarification.
Quantity in commerce: 295 kits
Distribution: Nationwide Distribution -- MA.
Product codes and lots: Catalog number: ASK-09903-CMC, Lot number RF9060715

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)