Z-1653-2009

Arrow Pediatric Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, 5 Fr., 2 Lumen, 13cm...

Name: Z-1653-2009 Arrow Pediatric Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, 5 Fr., 2 Lumen, 13cm...
Creator: Arrow International Inc
Published: 2009-06-17
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2009-06-17 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of Arrow Pediatric Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, 5 Fr., 2 Lumen, 13cm catheter length, Catalog number: CS-14502 on 2009-06-17. The reason FDA records is "The spring wire guide is too large in diameter to pass through the needle, dilator and catheter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1653-2009
Status: Terminated
Initiated: 2009-06-17
Posted: 2009-07-07
Terminated: 2009-12-03
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow Pediatric Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, 5 Fr., 2 Lumen, 13cm catheter length, Catalog number: CS-14502.
Product code: DQY Catheter, Percutaneous
Reason for recall: The spring wire guide is too large in diameter to pass through the needle, dilator and catheter.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Arrow notified consignees by letter on/about 06/17/2009. They were instructed to cease use and distribution and quarantine all affected product. They were to contact Arrow's Customer Service Department for a Return Authorization Number. Enclosed was a Recall Acknowledgement & Stock Status Form to be completed and faxed to Arrow International to verify receipt of notification and acknowledge the amount of return.
Quantity in commerce: 3019 units
Distribution: Worldwide distribution, including USA, Argentina, Brazil, India, Taiwan and Thailand.
Product codes and lots: Catalog number: CS-14502, Lot numbers: RF7019488 and RF7029944.

Product code DQY

K862056Class II[Central Venous][multi-Lumen] Catheter W/flex TipArrow Intl., Inc. / cleared 1986-08-25

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)