FDA Medical Device Recalls (openFDA)
Abbott Laboratories, Inc: ARCHITECT i System External Waste Pump
- Recall number
- Z-0795-03
- Recalling firm
- Abbott Laboratories, Inc
- Product
- ARCHITECT i System External Waste Pump
- Status
- Terminated
- Initiated
- 2003-01-27
- Posted
- 2003-05-09
- Terminated
- 2004-04-07
- Reason
- External waste pump has metal edge around perimeter sharp enough to cause scratch or cut.
- Root cause
- Other
- 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.
- Quantity
- 1318 units
- Distribution
- 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
- Lot, serial or model codes
- Product List Number 8C94-99, no lot numbers or codes
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1628664
- Firm city
- Irving
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28