Z-1633-2014Class II

Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter...

Name: Z-1633-2014 Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter...
Creator: Arrow International Inc
Published: 2013-07-17
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2013-07-17 / Terminated / root cause: labeling and UDI

FDA source

Arrow International Inc began a recall of Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central... on 2013-07-17. FDA classified it as Class II and gives the reason as "The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe; however, the kit contains, and should state, Introducer Needle...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1633-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-17
Posted: 2014-05-19
Terminated: 2015-03-30
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe; however, the kit contains, and should state, Introducer Needle: 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe. As a result of this labeling inconsistency, if the clinician were to place the needle under x-r
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Arrow sent an Urgent Medical Device Recall Notification letter dated July 17, 2013, was sent to the customer requesting they discontinue use and quarantine any remaining affected product for return to Arrow. Our records indicate that you have received products that are subject to this voluntary recall. We are now asking that you take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-800-343-2935, Attn: Customer Service. This will allow us to document the amount of product you have on hand for return. Your sales representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions and assistance for the return of product to Arrow International. 3. If you have no affected stock, please complete the 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.
Quantity in commerce: 4285
Distribution: US Distribution only to MI.
Product codes and lots: MF2016829 RM2072044 RM2034076 RM2095792 RM2056629 RM3015571 RM2069733

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1633-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1633-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-19

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)