Z-0116-2016Class II

Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal...

Name: Z-0116-2016 Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal...
Creator: Concentric Medical Inc
Published: 2015-08-19
License: https://open.fda.gov/license/

Concentric Medical, Inc. / initiated 2015-08-19 / Terminated / root cause: manufacturing process

FDA source

Concentric Medical Inc began a recall of Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating... on 2015-08-19. FDA classified it as Class II and gives the reason as "One Distal Access Catheter intended for distribution in Korea, was found at a US location". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0116-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-19
Posted: 2015-10-09
Terminated: 2015-10-09
Recalling firm: Concentric Medical, Inc.
Product: Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems.
Product code: DQY Catheter, Percutaneous
Reason for recall: One Distal Access Catheter intended for distribution in Korea, was found at a US location.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Issue was discovered by a sales representative during a visit for a case in Kentucky, where multiple Distal Access Catheters (DAC's) were being used. It was noticed that the reference number on one DAC carton did not match, even through the product labeling appeared to be the same. The mismatched unit was removed and returned to Concentric (Stryker). A formal recall letter was not issued as the product was returned after discovery. For further questions please call (510) 413-2263.
Quantity in commerce: 1
Distribution: US Distribution to one location in KY.
Product codes and lots: Lot no. 37603 Expiration date: September 2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0116-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0116-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-21	2015-10-09

Product code DQY

K133177Class IIModified Hd Guide CatheterConcentric Medical, Inc. / cleared 2014-02-25

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)