Severity
Moderate
FDA Devices recall · Reported September 2, 2015
Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid fu…
Baxter Healthcare Corp. recalled MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C… - a moderate-severity action.
MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C… was recalled by Baxter Healthcare Corp. in September 2, 2015. Reason: Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the san…. Check the official notice for the remedy. Verify recall #Z-2471-2015 with the FDA Devices before acting.
The recall
Baxter Healthcare Corp. issued this moderate-severity FDA Devices recall-Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the san….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2471-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2471-2015) was formally reported on September 2, 2015, with the manufacturer initiating the action on February 25, 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 260,244 units, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reproce… Distribution data in the federal record shows the product reached: Worldwide Distribution - US: Nationwide + American Samoa + District of Columbia + Guam + Northern Mariana Islands + Puerto Rico; *** FOREIGN: Antigua, Argentina, Australia, Bahamas, Barbados, Bermuda, Brazil, Canada, Ch…. 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.
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.
Severity
Moderate
Affected scope
260,244 units
Related Recalls
6
3 from same agency
MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C4483. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler set juncture.
Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2471-2015 |
| Date reported | September 2, 2015 |
| Date initiated | February 25, 2013 |
| Recalling firm | Baxter Healthcare Corp. |
| Firm location | Deerfield, IL |
| Affected scope | 260,244 units |
| Distribution | Worldwide Distribution - US: Nationwide + American Samoa + District of Columbia + Guam + Northern Mariana Islands + Puerto Rico; *** FOREIGN: Antigua, Argentina, Australia, Bahamas, Barbados, Bermuda, Brazil, Canada, Chile, Colombia, Cuba,… |
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.
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.
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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 September 2, 2015. 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.