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Terminated

LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group

FDA Recall Z-2568-2014 · Posted 2014-09-03

Recalling FirmDatascope Corporation
Recall StatusTerminated
Product CodeDSP
Date Initiated2014-08-11
Date Terminated2015-02-05
Product Quantityone unit

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.

Firm Action

Maquet Inc.is sued an Urgent Medical Device Recall Letter/ Fax Back Form dated August 11, 2014. Customers are asked to quarantine the affected product and upon return they will be provided with an exchanged unaffected product. The attached form should be completed an returned to Maquet Inc. Questions can be directed to Maquet Technical Support at (888) 627-8383 - Press option "3" followed by option "1" Monday through Friday between the hours of 8 am and 5 pm (EST).

Root Cause

Labeling False and Misleading

Distribution Pattern

US Distribution to TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041281DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIESDatascope Corp. · 2004-06-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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