Z-0331-2017Class II

HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed...

Name: Z-0331-2017 HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed...
Creator: Arrow International Inc
Published: 2016-09-02
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2016-09-02 / Terminated / root cause: labeling and UDI

FDA source

Arrow International Inc began a recall of HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with... on 2016-09-02. FDA classified it as Class II and gives the reason as "Labeling inconsistency". 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-0331-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-02
Posted: 2016-11-02
Terminated: 2020-02-20
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with integral flushing/balloon test chamber, enabling the practitioner to prepare, test, and insert the catheter without exposing it to external contamination.
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: Labeling inconsistency
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Arrow sent an Urgent Medical Device Recall Notification letter dated September 20, 2016, to all affected customers via FedEx 2-day air. The letter identified the problem and provided instructions to immediately discontinue use and quarantine any products with the associated lot numbers indicated in the letter. If product was found, customers were asked to complete the Recall Acknowledgement Form and a Customer Service Rep will issue a Return Goods Authorization (RGA) Number for the product's return. Disposition of recalled product will be scrapped. For further questions, please call (610) 378-0131
Quantity in commerce: 330 units in US and 1,031 units OUS
Distribution: Nationwide distribution
Product codes and lots: Lot # 16F15C0114, 16F15D0003, 16F15A0072, 16F15F0031, 16F15F0090, 16F15H0037, 16F16B0001, 16F16B0014, 16F16C0056, 16F16C0079, 16F16C0109, 16F16E0004, 16F16E0030

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0331-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0331-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-11-02

Product code DQO

K895268Class IIArrow Hands-Off Thermo-PaceArrow Intl., Inc. / cleared 1989-11-06

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)