MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be use
Summary
The FDA issued a Class II for MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usa by CAREFUSION. Reason: A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.
Details
Source
Device Recall
External ID
Z-1995-2021
Action Date
2021-07-07
Status
Terminated
Category
device
Product Description
MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.
Lot/Code Info: Catalog Number:MP9246-C GTIN: 10885403237157 Lot Number: 20087194
Quantity Affected: 100 units
Reason for Recall
A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.
Distribution
U.S.: TN O.U.S.: None
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-09
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 52 device recalls issued in the same week, part of 403 device-related FDA actions this month.
CAREFUSION has 25 FDA actions in our database, including 25 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CAREFUSION) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CAREFUSION have FDA actions?
CAREFUSION has 25 FDA actions in our database, including 25 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1995-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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