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Terminated

AEROSET System External Waste Pump

FDA Recall Z-0796-03 · Posted 2003-05-09

Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2003-01-27
Date Terminated2004-04-07
Product Quantity461 units

Reason for Recall

External waste pump has metal edge around perimeter sharp enough to cause scratch or cut.

Firm Action

Firm sent 01/27/2003 letter to all consingees informing them of the issue. US Cutomer Reply form will be distributed with the customer letter.

Root Cause

Other

Distribution Pattern

Nationwide and to the following foreign countries: Mexico, Chilie, Columbia, Dominican Republic, Hong Kong, Guatemala, Argentina, Canada, Australia, Venezuela, Brazil, Germany, New Zealand, Malaysia, Japan, Taiwan, Korea, Singapore, Thailand

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K980367AEROSET SYSTEMAbbott Laboratories · 1998-04-01

Official Source

View FDA Recall →

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

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