Z-2488-2010

MAC Two-Lumen Central Venous Access kit with Integral Hemostasis Valve for use with 7 - 8 Fr. Catheters

Name: Z-2488-2010 MAC Two-Lumen Central Venous Access kit with Integral Hemostasis Valve for use with 7 - 8 Fr. Catheters
Creator: Arrow International Inc
Published: 2010-07-29
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2010-07-29 / Terminated

FDA source

Arrow International Inc began a recall of MAC Two-Lumen Central Venous Access kit with Integral Hemostasis Valve for use with 7 - 8 Fr. Catheters on 2010-07-29. The reason FDA records is "Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2488-2010
Status: Terminated
Initiated: 2010-07-29
Posted: 2010-09-25
Terminated: 2012-07-05
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: MAC Two-Lumen Central Venous Access kit with Integral Hemostasis Valve for use with 7 - 8 Fr. Catheters
Product code: DYB Introducer, Catheter
Reason for recall: Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle
FDA root cause: Mixed-up of materials/components
Action: The recalling firm issued an Urgent Medical Device Recall letter dated 7/23/2010 along with a a recall acknowledgement and stock status form.
Quantity in commerce: 16
Distribution: The product was shipped to medical centers and hospitals nationwide and to Australia, New Zealand, and Europe.
Product codes and lots: Product # AK-11142-B, Lot # RF0033311

Product code DYB

K002507Class IITwo-Lumen Central Venous Access Kit with Hemostasis Valve/side PortArrow Intl., Inc. / cleared 2001-03-21

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)