Z-1611-2013Class II

Pinnacle Destination Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a...

Name: Z-1611-2013 Pinnacle Destination Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a...
Creator: Terumo Medical Corporation
Published: 2013-05-30
License: https://open.fda.gov/license/

Terumo Medical Corp. / initiated 2013-05-30 / Terminated / root cause: labeling and UDI

FDA source

Terumo Medical Corporation began a recall of Pinnacle Destination Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of... on 2013-05-30. FDA classified it as Class II and gives the reason as "Medical devices were incorrectly labeled with extended expiration dates". 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-1611-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-30
Posted: 2013-06-27
Terminated: 2013-10-30
Recalling firm: Terumo Medical Corp.
Product: Pinnacle Destination Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature.
Product code: DYB Introducer, Catheter
Reason for recall: Medical devices were incorrectly labeled with extended expiration dates.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The recalling firm notified consignees by letter on 5/30/2013. The letter was flagged as an urgent product bulletin addressed to risk managers. The notification advised customers to immediately discontinue use and quarantine any available stock for subsequent instructions to be provided for pick-up and replacement.
Quantity in commerce: 20 units
Distribution: Nationwide Distribution.
Product codes and lots: Lot MM27

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1611-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1611-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-27
Z-1612-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-27

Product code DYB

K091329Class IIPinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. / cleared 2009-05-29

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)