Recall Z-2568-2014— Datascope Corporation

Name: FDA recall Z-2568-2014
Creator: U.S. Food and Drug Administration
Published: 2014-08-11

Class III · Terminated

Class III FDA medical device recall by Datascope Corporation, initiated 2014-08-11, terminated 2015-02-05. It names one FDA 510(k) clearance: K041281. Product: LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group. Reason: During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter..

Recalling firm: Datascope Corporation
Classification: Class III
Status: Terminated
Initiated: 2014-08-11
Terminated: 2015-02-05
Firm location: Fairfield, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K041281 — DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIESDatascope Corp.·cleared 2004-06-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group

Reason for recall

During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter.

Data sourced from openFDA. This site is unofficial and independent of the FDA.