Z-1708-2016Class II

Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877...

Name: Z-1708-2016 Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877...
Creator: Stryker Sustainability Solutions
Published: 2016-04-28
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2016-04-28 / Terminated / root cause: labeling and UDI

FDA source

Stryker Sustainability Solutions began a recall of Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording... on 2016-04-28. FDA classified it as Class II and gives the reason as "Mislabeled for size". 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-1708-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-28
Posted: 2016-05-23
Terminated: 2016-06-29
Recalling firm: Stryker Sustainability Solutions
Product: Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
Product code: NLH Catheter, Recording, Electrode, Reprocessed
Reason for recall: Mislabeled for size
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: The firm sent out customer notification letters on 04/28/16. Customers are instructed to discontinue the use of affected lots of recalled product. Other EP Catheters reprocessed by Stryker Sustainability Solutions should be considered as alternatives. A Recall Effectiveness Check Form including the quantity of affected devices shipped to facility is enclosed. Please complete the Recall Effectiveness Check Form and indicate if any devices from the affected lots remain in your inventory. This form needs to be completed even if no affected product is found. Please return the completed and signed Recall Effectiveness Check Form to your local Stryker Sustainability Sales Representative or email to [email protected] or mail to: Stryker Sustainability Solutions 1810 West Drake Drive Tempe, AZ, 85283 Attn: Jodie Rueckert If the form indicates that affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Customers will receive a credit for all affected devices returned. Adverse reactions or quality problems experienced with the use of this product may be reported to: - Stryker Sustainability Solutions Complaint Hotline: +1(888) 888-3433 X5555 - http://www.stryker.com/productexperience/ - The FDAs MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. On 05/12/16 the firm sent out a clarification letter to emphasize that use of affected lots of product should be discontinued. In addition, SSS would like to note that, use of devices larger than expected may result in excess force applied to the blood vessel. The risk to the patient can vary from a prolongation in procedure time, vessel rupture, organ damage or other unforeseen consequences. Some of these injuries may require surgery or other procedures to remedy. Any questions contact the Stryker Sustainability Solutions Sales Representative or Regulatory Affairs.
Quantity in commerce: 18 devices
Distribution: Distributed in the state of NY and the country of Canada.
Product codes and lots: Catalog Number: 401450 Lot Number: 2561683E Expiration Date: 5/13/2017 Catalog Number: 401877 Lot Number: 2555866E Expiration Date: 5/6/2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1708-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1708-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-23

Product code NLH

K012708Class IIElectrophysiology CatheterAlliance Medical Corp. / cleared 2002-08-13

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)