Z-2136-2016Class II

Arrow, Arrowg+ard and Arrowg+ard Blue Plus Pressure Injectable Central Venous Catheter

Name: Z-2136-2016 Arrow, Arrowg+ard and Arrowg+ard Blue Plus Pressure Injectable Central Venous Catheter
Creator: Arrow International Inc
Published: 2016-06-02
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2016-06-02 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. Product Usage: Indicated to provide short-term (<30 days) central... on 2016-06-02. FDA classified it as Class II and gives the reason as "Arrow is recalling these products due to the possibility that although the kit is labeled as containing a 20 cm catheter, a 16 cm catheter may be packaged in the kit". 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-2136-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-02
Posted: 2016-07-06
Terminated: 2017-08-25
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. Product Usage: Indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring cental venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy, infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values, frequent blood sampling or blood/blood component infusions, infusion of incompatible medications, central venous pressure monitoring, lack of usable peripheral IV sites, replacement of multiple peripheral sites for IV access and injection of contrast media.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Arrow is recalling these products due to the possibility that although the kit is labeled as containing a 20 cm catheter, a 16 cm catheter may be packaged in the kit.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Arrow mailed an Urgent Medical Device Recall Notification letter to customers requesting they immediately discontinue distribution and quarantine any products with the affected lot numbers. A Recall Acknowledgement Form was included with the notification letter for customers to complete and email to recalls @teleflex.com indicating the amount of product on hand.
Quantity in commerce: 1, 170 units
Distribution: US Nationwide Distribution: in the states of MA, CA, IL, TN, IL
Product codes and lots: Device Listing # D040746, FDA Product Code FOZ, Product Code: ASK-45854-PUC, ASK-45854-PSFM, ASK-42854-PCSM and ASK-42854-PBW4 Lot # 23F15F1786, 23F15F1862, 23F15G0818, 23F15J0162, 23F15H0460, 23F15F0943, 23F15G0729, 23F15J1084

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2136-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2136-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-13	2016-07-06

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)