FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Automated peritoneal dialysis (APD) cycler
- Recall number
- Z-1565-2016
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Automated peritoneal dialysis (APD) cycler
- Status
- Terminated
- Initiated
- 2016-02-16
- Posted
- not on file
- Terminated
- 2016-12-23
- Reason
- Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating the total recommended solution therapy volume. Specifically, the instructions do not specify the need for an extra 200 mL of PD solution in order to prime the patient line and for air purge operations. The tot
- Root cause
- Under Investigation by firm
- Action
- An Urgent Device Correction communication was sent to the one affected customer via U.S.P.S., first class mail on 02/11/2016. A Clinician Guide Addendum was created to instruct clinicians of the extra 200 mL of PD solution required to prime the patient line and for air purge operations. This Addendum was provided as an attachment to the Urgent Device Correction communication letter.
- Quantity
- 10 units
- Distribution
- US Consignee: NY ***Foreign Consignee: Ecuador
- Lot, serial or model codes
- N/A
- 510(k) numbers
- ["K151525"]
- PMA numbers
- not on file
- Product code
- FKX
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- 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
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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