Z-1141-2007

Embrace Enteral Pump

Name: Z-1141-2007 Embrace Enteral Pump
Creator: Ross Products Division Abbott Laboratories
Published: 2007-06-21
License: https://open.fda.gov/license/

Ross Products Division Abbott Laboratories / initiated 2007-06-21 / Terminated / root cause: manufacturing process

FDA source

Ross Products Division Abbott Laboratories began a recall of Embrace Enteral Pump on 2007-06-21. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1141-2007
Status: Terminated
Initiated: 2007-06-21
Posted: 2007-08-08
Terminated: 2012-09-20
Recalling firm: Ross Products Division Abbott Laboratories
Product: Embrace Enteral Pump
Product code: LZH Pump, Infusion, Enteral
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.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Consignees were notified by letter dated 6/25/2007. The firm sent a revised letter on 07/26/2007.
Quantity in commerce: 9,600 units
Distribution: The product was distributed throughout the US.
Product codes and lots: List #55335 & 55336

Product code LZH

K031407Class IIRoss Embrace Enteral PumpRoss Product Div. Abbott Laboratories / cleared 2003-05-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)