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[Recalled] MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5C4482. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications wh

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductMiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5C4482. 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 transfe
Brand / manufacturerBaxter Healthcare Corp.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2472-2015
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date25 February 2013

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard 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 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Baxter Healthcare Corp.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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