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

MiniCap Extended Life PD Transfer Set recalled by Baxter Healthcare

Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Set, 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: 5C4449; All Lots

Quantity recalled33,474 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-2473-2015
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: Heart & Vascular 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

MiniCap Extended Life PD Transfer Set. Product Code 5C4449. 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.

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

Why was it recalled?

Which lots are affected?

Product Code: 5C4449; 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 64928

This product is part of a recall event; the main page for the event is MiniCap Extended Life PD Transfer Set (6") with Twist Clamp recalled.

Reported	Class	Recall	Company	Reason	Where
2 Sep 2015	CLASS II	MiniCap Extended Life PD Transfer Set (6") with Twist Clamp recalled	Baxter Healthcare	Foreign Material	Nationwide
2 Sep 2015	CLASS II	CAPD Solution Transfer Set with Locking Connector recalled	Baxter Healthcare	Foreign Material	Nationwide
2 Sep 2015	CLASS II	MiniCap Extended Life PD Transfer Set Extra Short (4") recalled	Baxter Healthcare	Foreign Material	Nationwide

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