Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 31, 2016
1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the patient to empty at the beginning of therapy (initial drain). The operator can stop…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Baxter Healthcare Corp. recalled 1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device … - a moderate-severity action.
1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device … was recalled by Baxter Healthcare Corp. in August 31, 2016. Reason: In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the patient to em…. Check the official notice for the remedy. Verify recall #Z-2609-2016 with the FDA Devices before acting.
The recall
Baxter Healthcare Corp. issued this moderate-severity FDA Devices recall-In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the patient to em….
- Moderate
- severity level
- Class II
- classification
- August 31, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2609-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2609-2016) was formally reported on August 31, 2016, with the manufacturer initiating the action on October 7, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Baxter Healthcare Corp. is listed as the recalling firm, operating out of Deerfield, IL. Federal records list the affected scope as *** 1) Product Codes 5C4471 and 5C4471R: Approximately 48,600 units; *** 2) Product Codes 5C8310 and 5C8310R: Approxiamtely 16,990 units.
The documented reason for this recall is: In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the patient to empty at the beginning of therapy (initial drain). The operator can stop, but cannot bypass, the active Initial … Distribution data in the federal record shows the product reached: Worldwide distribution. US nationwide including Puerto Rico; Australia, Canada, New Zealand, and Japan. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
*** 1) Product Codes 5C4471 and 5C4471R: Approximately 48,600 units; *** 2) Product Codes 5C8310 and 5C8310R: Approxiamtely 16,990 units
Related Recalls
6
3 from same agency
Product description
1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
Reason for recall
In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the patient to empty at the beginning of therapy (initial drain). The operator can stop, but cannot bypass, the active Initial Drain. This is to mitigate against Unintended Increased Intraperitoneal Volume (IIVP). This can cause serious problems in patients with unrelated a co-morbid condition of ascites.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2609-2016 |
| Date reported | August 31, 2016 |
| Date initiated | October 7, 2013 |
| Recalling firm | Baxter Healthcare Corp. |
| Firm location | Deerfield, IL |
| Affected scope | *** 1) Product Codes 5C4471 and 5C4471R: Approximately 48,600 units; *** 2) Product Codes 5C8310 and 5C8310R: Approxiamtely 16,990 units |
| Distribution | Worldwide distribution. US nationwide including Puerto Rico; Australia, Canada, New Zealand, and Japan |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2609-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.. Recalled by Baxter Healthcare Corp.. Units affected: *** 1) Product Codes 5C4471 and 5C4471R: Approximately 48,600 units; *** 2) Product Codes 5C8310 and 5C8310R: Approxiamtely 16,990 units.
Why was this product recalled? ▼
In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the patient to empty at the beginning of therapy (initial drain). The operator can stop, but cannot bypass, the active Initial Drain. This is to mitigate against Unintended Increased Intraperitoneal Volume (IIVP). This can cause serious problems in patients with unrelated a co-morbid condition of ascites.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 31, 2016. Severity: Moderate. Recall number: Z-2609-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution. US nationwide including Puerto Rico; Australia, Canada, New Zealand, and Japan.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2609-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 31, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.