Z-3197-2018Class II

ARROW Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm

Name: Z-3197-2018 ARROW Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm
Creator: Arrow International Inc
Published: 2018-07-30
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2018-07-30 / Terminated / root cause: labeling and UDI

FDA source

Arrow International Inc began a recall of ARROW Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for... on 2018-07-30. FDA classified it as Class II and gives the reason as "Products are labeled with an incorrect expiration date". 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-3197-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-30
Posted: 2018-09-19
Terminated: 2019-07-11
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: ARROW Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording
Product code: DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Reason for recall: Products are labeled with an incorrect expiration date
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Arrow International notified US consignee notification by letter on 30 JUL 2018 via FedEx 2-day mail. Account action: immediately discontinue use and quarantine any products with the product codes and lot numbers listed above, so that the affected products can be returned to Arrow. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected].
Quantity in commerce: 7 eaches
Distribution: US in the state of PA
Product codes and lots: Lot/Batch Number:16F18A0010 Use By: 2023-12-31

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3197-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3197-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-19

Product code DRF

K945229Class IIArrow Multipolar Intracardiac Electrode CathetersArrow Intl., Inc. / cleared 1995-08-08

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)