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Terminated

Anestar and Anestar Plus Anesthesia System.

FDA Recall Z-0929-06 · Posted 2006-06-02

Recalling FirmDatascope Corp
Recall StatusTerminated
Product CodeBSZ
Date Initiated2006-03-17
Date Terminated2006-08-01
Product Quantity337 UNITS

Reason for Recall

The Anestar and Anestar Plus Anesthesia System may produce periods of high Positive End-Expiratory Pressure (PEEP), in both manual and mechanical ventilation mode due to an issue with the Applied Pressure Limit (APL) valve.

Firm Action

Field correction communications were sent 3/17/2006 to all accounts via certified mail, return receipt requested, signature required.

Root Cause

Other

Distribution Pattern

The units have been distributed to distributors and end-users such as hospitals and clinics nationwide. There are 3 foreign accounts in Australia, El Salvador, and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K001988MODULARHeyer America, Inc. · 2001-02-05

Official Source

View FDA Recall →

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

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