Z-1823-2012Class II

Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter...

Name: Z-1823-2012 Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter...
Creator: Arrow International Inc
Published: 2012-06-07
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2012-06-07 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A The multiple-lumen... on 2012-06-07. FDA classified it as Class II and gives the reason as "Arrow is recalling the product due to the possibility of voids in the catheter hub which could lead to an interlumen crossover". 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-1823-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-07
Posted: 2012-06-19
Terminated: 2014-04-03
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A The multiple-lumen pressure injectable catheter permits venous access to central circulation and injection of contrast media. The ARROWg+ard(R) antimicrobial surface is intended to provide protection against catheter-related infections.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Arrow is recalling the product due to the possibility of voids in the catheter hub which could lead to an interlumen crossover.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Arrow International sent a Urgent Medical Device Recall Notification letter dated June 11, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to take the following action: 1. If you have affected stock, immediately discontinue use and quarantine any products with the catalog and lot numbers listed. 2. To return product complete the enclosed Recall Acknowledgement Form and fax to 1-800-343-2935, Attn: Customer Service. This will allow us to document the amount of the product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization ( RGA) Number and will provide instructions for the return of product to Arrow International. 3. If you have no affected stock, please complete t he enclosed Recall Acknowledgment Form and fax it to 1-800-343-2935, Attn: Customer Service. This will allow us to document your receipt of this letter. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-800-343-2935.
Quantity in commerce: 1,085
Distribution: USA (nationwide) AL, AZ, AR, CA, CO, FL, GA, IL, IN, KS, LA, MA, MI, MO, NV, NH, NC, OH, PA, TX, VA, WA, and WI.
Product codes and lots: Lot number RF2033361

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1823-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1823-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-19

Product code FOZ

K071538Class IIArrow, Arrowg+ard and Arrowg+ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. / cleared 2007-08-30

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)