Z-0844-2020Class II

Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle...

Name: Z-0844-2020 Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle...
Creator: Arrow International Inc
Published: 2019-12-12
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2019-12-12 / Open, Classified / root cause: labeling and UDI

FDA source

Arrow International Inc began a recall of Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide... on 2019-12-12. FDA classified it as Class II and gives the reason as "The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component of the kit". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0844-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-12-12
Posted: 2020-01-23
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels.
Product code: DQX Wire, Guide, Catheter
Reason for recall: The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component of the kit
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Arrow International issued an " Urgent Medical Device Recall Notice" to its US consignee on 12th Dec 2019 via FedEx 2-day mail. The letter states reason for recall, health risk and action to take: If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Please complete the enclosed Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to [email protected]. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. If you have no affected stock, please complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. Questions contact your local sales representative or Customer Service at 1-866-396-2111.
Quantity in commerce: 80 eaches
Distribution: US distribution to SC
Product codes and lots: Lot/Batch Number: PMC 23F19H0224

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0844-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0844-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-01-29	2020-01-23

Product code DQX

K810675Class IIArrow Radial Artery Catheterization SetArrow Intl., Inc. / cleared 1981-03-27

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)