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Terminated

Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm, rigid insertion stylet, sterile, REF CODE: RSR-M014S.

FDA Recall Z-0902-2007 · Posted 2007-06-06

Recalling FirmSurge Medical Solutions, LLC
Recall StatusTerminated
Product CodeDWF
Date Initiated2007-04-17
Date Terminated2009-03-10
Product Quantity2,211 for all Recalls Z-0892-0904-2007

Reason for Recall

The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.

Firm Action

Consignees were notified and requested to return the recalled products via recall letter dated 4/17/07.

Root Cause

Other

Distribution Pattern

Worldwide, USA, Argentina, Germany, Ireland, Italy, Lebanon, Saudi Arabia, Turkey, and the United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K964393CHASE RETROGRADE CARDIOPLEGIA CANNULAChase Medical, Inc. · 1997-04-23

Official Source

View FDA Recall →

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

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