CAREFUSION recalls MaxPlus bi fuse extension sets with 2 clear needleless connectors due to leakage issues in validation testing. Affected units may not meet safety standards for medical use.
A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.
CAREF: MaxPlus bi fuse extension sets with 2 clear needleless connectors are being recalled because a portion of the product failed validation testing for leakage. This could lead to improper medical use if the connectors leak.
The product failed validation testing for leakage, meaning it may not seal properly during medical use. This could cause fluid to leak, potentially leading to improper medication delivery or contamination.
Healthcare professionals and patients using the MaxPlus bi fuse extension sets with 2 clear needleless connectors for medical injections or infusions. Those who have the specific lot number 20087194 are most at risk.
Check for the product name 'MaxPlus bi fuse extension set' with 2 clear needleless connectors. The affected lot number is 20087194. The product was sold with catalog number MP9246-C and GTIN 10885403237157.
Identify the lot number on your product label; affected units have lot number 20087194.
The product failed validation testing for leakage, meaning it may not seal properly during medical use.
The recall record does not specify a remedy, so check the product details to see if it matches the affected lot number.
The recall indicates a leakage risk, but the record does not specify that it can cause serious injury in normal use.
We’ve drafted a message you can send CAREFUSION to request your refund or repair — edit it as you like.
Subject: Recall Z-1995-2021 — CAREFUSION CAREFUSION Hello, I own a CAREFUSION that is covered by recall Z-1995-2021 from CAREFUSION. 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.
