Z-2336-2017Class II

Arrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device permits venous access and catheter...

Name: Z-2336-2017 Arrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device permits venous access and catheter...
Creator: Arrow International Inc
Published: 2017-05-09
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2017-05-09 / Terminated / root cause: packaging

FDA source

Arrow International Inc began a recall of Arrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation on 2017-05-09. FDA classified it as Class II and gives the reason as "The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: -multiple infusions of fluids...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2336-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-09
Posted: 2017-06-12
Terminated: 2018-09-17
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation.
Product code: DQY Catheter, Percutaneous
Reason for recall: The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central 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 components infusions -infusion of incompatible medications -central venous pressure monitoring lack of usable peripheral IV sites -replacement of multiple peripheral sites for IV access
Root cause tag: packaging
FDA root cause: Packaging
Action: Arrow International sent an Urgent Medical Device Recall Notification Letter dated May 11, 2017, to affected customers. The firm's notification letter is requesting that customers immediately assess their current inventory and to discontinue and quarantine any product with the specific lot codes listed in the letter. In addition, customers were asked to complete the Recall Acknowledgement form and fax or email it back to Customer Service so they can receive a Returns Good Authorization Number for the product's return. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 27,485 units distributed in U.S., 4,371 units distributed internationally
Distribution: Worldwide Distribution - US (nationwide) and Canada
Product codes and lots: Material number: CDC-12703-1A, CDC-12802-1A, CDC-15703-1A, CDC-15703-B1A, CDC-15802-1A, Device Listing E426708

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2336-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2327-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2328-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2329-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2330-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2331-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2332-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2333-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2334-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2335-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2336-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2337-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2338-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12

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