Z-0658-2018Class II

ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes...

Name: Z-0658-2018 ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes...
Creator: Arrow International Inc
Published: 2017-10-17
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2017-10-17 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-CDC, AK-25142-F; Exp... on 2017-10-17. FDA classified it as Class II and gives the reason as "These finished good kits may contain the incorrect Springwire Guide (SWG)". 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-0658-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-17
Posted: 2018-02-20
Terminated: 2020-04-14
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-CDC, AK-25142-F; Exp. Dates Feb 2018 - Nov 2018
Product code: MPB Catheter, Hemodialysis, Non-Implanted
Reason for recall: These finished good kits may contain the incorrect Springwire Guide (SWG).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On October 17, 2017 an Urgent Medical Device recall letter from Arrow International was issued to customers requesting that customers review their inventory for product, which should immediately be discontinued and quarantined. The products are then to be returned to the firm. Questions or concerns can be directed to: Customer Service at 18662466990.
Quantity in commerce: 5,926 total
Distribution: Distribution US Nationwide
Product codes and lots: Lot numbers: Product Code AK-22142-CDC: 13F17A0021 13F17A0315 Product Code AK-22142-F: 13F17B0338 13F17E0067 Product Code AK-25142-CDC: 13F17E0340 Product Code AK-25142-F: 13F17A0207

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0658-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0647-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-20
Z-0648-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-20
Z-0649-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-20
Z-0650-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-20
Z-0651-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-20
Z-0652-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-20
Z-0653-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-20
Z-0654-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-20
Z-0655-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-20
Z-0656-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-20
Z-0657-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-20
Z-0658-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-20

Product code MPB

K993933Class II14 Fr Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+ard Blue Catheter for High Volume Infusions, ProArrow Intl., Inc. / cleared 2000-09-14

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)