Z-1409-04

Peritoneal Lavage Kits, Model number AK-09001

Name: Z-1409-04 Peritoneal Lavage Kits, Model number AK-09001
Creator: Arrow International Inc
Published: 2004-08-02
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2004-08-02 / Terminated

FDA source

Arrow International Inc began a recall of Peritoneal Lavage Kits, Model number AK-09001 on 2004-08-02. The reason FDA records is "wrong introducer needle in some kits". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1409-04
Status: Terminated
Initiated: 2004-08-02
Posted: 2004-08-25
Terminated: 2005-08-22
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Peritoneal Lavage Kits, Model number AK-09001
Product code: GBW Catheter, Peritoneal
Reason for recall: wrong introducer needle in some kits
FDA root cause: Other
Action: The recalling firm issued a recall letter to their customers on 8/9/04. The letter instructed the accounts to return the product.
Quantity in commerce: 9100 units
Distribution: The product was shipped to 45 distributors, 265 medical facilities nationwide, 7 firm sales representatives, 12 government accounts, and 9 foreign accounts.
Product codes and lots: Lot numbers: RF3111152 exp. 5/08, RF3121739 exp. 8/06, RF4012282 exp. 7/08, RF4012530 exp. 7/08, RF4034376 exp. 10/06, RF4034554 exp. 11/08, RF4045029 exp. 11/08, and RF4066325 exp. 1/09.

Product code GBW

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)