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Terminated

A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. Part numbers 0632F-PA0000X (US domestic) and 0632B-00014 (international)

FDA Recall Z-2689-2016 · Posted None

Recalling FirmMindray DS USA, Inc. dba Mindray North America
Recall StatusTerminated
Product CodeBSZ
Date Initiated2016-06-15
Date Terminated2017-03-28
Product Quantity167 units (165 units - US) and (2 units - International)

Reason for Recall

Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery System.

Firm Action

Mindray sent via certified mail with return receipt a recall letter dated June 15, 2016 to their affected customers. Mindray will replace the gasket on all e-size cylinder yokes on the affected A7 systems. Customer was instructed to contact their local Mindray Service Representative to arrange for this replacement. Customers can continue to use their A7 system while awaiting the replacement of the gasket(s). Customers can contact Ms. Diane Arpino, Director, Quality Operations and Regulatory Affairs via email to: [email protected] or via telephone to: (201)995-8407

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide Distribution to AL, MA, MD, MN, MO, NE, NJ, OK, OR, PA and VA; and Canada

Official Source

View FDA Recall →

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

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