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Terminated

Embrace Enteral Pump

FDA Recall Z-1141-2007 · Posted 2007-08-08

Recalling FirmRoss Products Division Abbott Laboratories
Recall StatusTerminated
Product CodeLZH
Date Initiated2007-06-21
Date Terminated2012-09-20
Product Quantity9,600 units

Reason for Recall

Continued use of the pump may cause the door pivot point on the back of the pump to crack or break. This will cause the pump to shut down and stop the initiation of enteral feeding.

Firm Action

Consignees were notified by letter dated 6/25/2007. The firm sent a revised letter on 07/26/2007.

Root Cause

Equipment maintenance

Distribution Pattern

The product was distributed throughout the US.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031407ROSS EMBRACE ENTERAL PUMPRoss Product Div. Abbott Laboratories · 2003-05-20

Official Source

View FDA Recall →

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

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