Baxter Healthcare recalls MiniCap Extended Life PD Transfer Sets with specific product codes due to lack of regulatory clearance. Affected units may not be approved for medical use.
Devices distributed lacked regulatory clearance.
Baxter Healthcare is recalling certain MiniCap Extended Life PD Transfer Sets because they were distributed without proper regulatory clearance. This means the devices may not meet safety standards for medical use.
The devices lack regulatory clearance, meaning they have not been approved by the relevant medical authorities for safe use. This could lead to improper medical procedures if used without proper validation.
Healthcare providers and patients using the recalled MiniCap Extended Life PD Transfer Sets. Those most at risk are medical professionals handling the devices without proper clearance.
Check for product codes: 5C4482S, R5C4482, R5C4483, or R5C4484. Look for specific lot numbers and expiration dates listed in the recall notice.
Identify if your MiniCap Extended Life PD Transfer Set has product codes 5C4482S, R5C4482, R5C4483, or R5C4484.
The devices were distributed without regulatory clearance, meaning they have not been approved for medical use.
The recall does not specify a stop-use instruction; affected units may be used but are not approved for medical procedures.
Check for product codes 5C4482S, R5C4482, R5C4483, or R5C4484 and corresponding lot numbers listed in the recall notice.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0831-2022 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-0831-2022 from Baxter Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
