Z-1845-2015Class II

Prestige Plus 185cm J-Tip: Part number: 9185J

Name: Z-1845-2015 Prestige Plus 185cm J-Tip: Part number: 9185J
Creator: Volcano Corporation
Published: 2015-06-04
License: https://open.fda.gov/license/

Volcano Corporation / initiated 2015-06-04 / Terminated / root cause: labeling and UDI

FDA source

Volcano Corporation began a recall of Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both... on 2015-06-04. FDA classified it as Class II and gives the reason as "During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time...". 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-1845-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-04
Posted: 2015-06-25
Terminated: 2015-10-27
Recalling firm: Volcano Corporation
Product: Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
Product code: DQX Wire, Guide, Catheter
Reason for recall: During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Volcano sent an Urgent Medical Device Recalls lettersdated June 4, 2015 via Federal Express to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine product inventory, quarantine the affected product, complete the attached Customer Return form, and contact Volcano Customer Service at 800-228-4728, option 4 to arrange for the return of any product in inventory.
Quantity in commerce: 162 total (both devices)
Distribution: US Nationwide Distribution and one account in Canada.
Product codes and lots: Product number 9185J; lot number 50004551/005-060, serial numbers 005-060.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1845-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1844-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-01	2015-06-25
Z-1845-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-01	2015-06-25

Product code DQX

K111395Class IIPrimewire Prestige PlusVolcano Corporation / cleared 2011-08-01

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)