CLASS II Device recall · Reported 2 Sep 2015 · FDA Enforcement Report

CAPD Solution Transfer Set with Locking Connector recalled

Baxter Healthcare is recalling CAPD Solution Transfer Set with Locking Connector, distributed nationwide in the US. The recall was initiated on 25 Feb 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: 5C4160; All Lots

Quantity recalled35,460 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2474-2015
FDA event ID: 64928
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Terminated
Recall initiated: 25 Feb 2013
FDA classified: 27 Aug 2015
Reported: 2 Sep 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

25 Feb 2013	Recall initiated by company
27 Aug 2015	Classified by FDA	+913 days
2 Sep 2015	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. intended for use with containers of DIANEAL peritoneal dialysis solution.

Where it was distributed

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, Curacao, Dominican Republic, Ecuador, El Salvador, France (New Caledonia), Guatemala, Guyana, Honduras, Hong Kong, India, Indonesia, Jamaica, Japan, Macau, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Suriname, Taiwan, Thailand, Trinidad and Tobago, United Kingdom (Cayman Islands), Uruguay, Venezuela

Nationwide District of Columbia Puerto Rico

Questions about this recall

Is CAPD Solution Transfer Set with Locking Connector recalled?

Yes. Baxter Healthcare recalled CAPD Solution Transfer Set with Locking Connector on 25 Feb 2013. The recall is Class II and its status is Terminated. Recall number Z-2474-2015.

Why was it recalled?

Which lots are affected?

Product Code: 5C4160; All Lots

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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