Z-2493-2010

Two-Lumen Central Venous Catheterization kit with Blue FlexTip ARROW g+ard Blue PLUS Catheter, Sharps Safety...

Name: Z-2493-2010 Two-Lumen Central Venous Catheterization kit with Blue FlexTip ARROW g+ard Blue PLUS Catheter, Sharps Safety...
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 Two-Lumen Central Venous Catheterization kit with Blue FlexTip ARROW g+ard Blue PLUS Catheter, Sharps Safety Features, and Maximal Barrier Precautions 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-2493-2010
Status: Terminated
Initiated: 2010-07-29
Posted: 2010-09-25
Terminated: 2012-07-05
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Two-Lumen Central Venous Catheterization kit with Blue FlexTip ARROW g+ard Blue PLUS Catheter, Sharps Safety Features, and Maximal Barrier Precautions
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
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: 15
Distribution: The product was shipped to medical centers and hospitals nationwide and to Australia, New Zealand, and Europe.
Product codes and lots: Product # CDC-45802-B1A, Lot # RF9127302

Product code FOZ

K993691Class IIArrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. / cleared 2000-03-08

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)