FDA Medical Device Recalls (openFDA)
Alaris Medical Systems Inc: Model 8100 Series Medley Medication Safety System Pump Module
- Recall number
- Z-0568-05
- Recalling firm
- Alaris Medical Systems Inc
- Product
- Model 8100 Series Medley Medication Safety System Pump Module
- Status
- Terminated
- Initiated
- 2004-11-10
- Posted
- 2005-03-03
- Terminated
- 2005-09-02
- Reason
- The device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module. To date there have been complaints from three (3) different customer locations.
- Root cause
- Other
- Action
- A device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module.
- Quantity
- 55,200
- Distribution
- United States and Canada
- Lot, serial or model codes
- Serial Numbers 2326101 thru 9861567
- 510(k) numbers
- ["K950419","K012383"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3003879246
- Firm city
- San Diego
- Firm state
- CA
- 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