Z-2267-2008

Cannon II Plus, Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff to Tip: 19cm...

Name: Z-2267-2008 Cannon II Plus, Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff to Tip: 19cm...
Creator: Arrow International Inc
Published: 2008-06-10
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2008-06-10 / Terminated / root cause: design

FDA source

Arrow International Inc began a recall of Cannon II Plus, Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff to Tip: 19cm, CS-15242-SPM, Intended for single use only... on 2008-06-10. The reason FDA records is "The tips may not have been adequately welded to the catheter body". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2267-2008
Status: Terminated
Initiated: 2008-06-10
Posted: 2008-09-17
Terminated: 2009-12-03
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Cannon II Plus, Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff to Tip: 19cm, CS-15242-SPM, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA The product is used for long term hemodialysis vascular access.
Product code: MSD Catheter, Hemodialysis, Implanted
Reason for recall: The tips may not have been adequately welded to the catheter body.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were notified by letter on/about 06/10/2008. They were instructed to: 1. Cease use and distribution and quarantine all affected product immediately. 2. Contact Arrows Customer Service Department for a Return Authorization Number, enter the number on an enclosed Recall Acknowledgement & Stock Status Form and 3. Immediately fax back the form to Arrow International. All affected product is to be returned to Arrow International. A letter containing the recall information was enclosed for physicians who have implanted catheters. Contact Arrow's Customer Service at 1-800-523-8446 for assistance.
Quantity in commerce: 79248 units (total for all catheters listed)
Distribution: U.S. Nationwide, Albania, Argentina, Australia, Belgium, Brazil, Canada , Chile, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Italy, Latvia, Liechtenstein, Lithuania, Mexico, Netherlands, New Zealand, Pakistan, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Turkey, UK and the Ukraine
Product codes and lots: Lot #RL7075164, RL7064972, RL7044661, RL7034319, RL7013952, RL6123683, RL6113590, RL6103342, RL6103321, RL6082972, RL6062811, RL6052578, RL6032233, RL6022006, RL5111401, RL5111314, RL5111273, RL5090749, RF5071974, and RF5060633.

Product code MSD

K040078Class IICannon II PlusArrow International, Inc. / cleared 2004-02-13

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)