Z-1995-2021Class II

MaxPlusTM bi fuse extension set with 2 clear needleless connectors -

Name: Z-1995-2021 MaxPlusTM bi fuse extension set with 2 clear needleless connectors -
Creator: Carefusion
Published: 2021-06-09
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2021-06-09 / Terminated

FDA source

CAREFUSION began a recall of MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injection, intermittent... on 2021-06-09. FDA classified it as Class II and gives the reason as "A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1995-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-09
Posted: 2021-07-01
Terminated: 2024-07-08
Recalling firm: CareFusion 303, Inc
Product: 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.
Product code: FPA Set, Administration, Intravascular
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.
FDA root cause: Under Investigation by firm
Action: On 06/09/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification letter via email and FedEx to customers informing them that a validation lot was inadvertently released to the US market. This product did not meet the validation testing criteria regarding leakage. Potential health consequences associated with the use of the non-validated product is under-infusion. Customers are instructed to: 1. Immediately review their inventory for the specific Catalog (Ref) and lot numbers listed. Destroy all product subject to the recall following their institutions process for destruction. The Recalling Firm will replace discarded product. 2. Share this recall notification with all users within or outside their facility network to which you they have further distributed the affected products to ensure they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the Recalling Firm's contact noted on the form (BD Post Market Quality Email: [email protected], Or Fax No.: 312-949-0236) whether or not they have any of the impacted material so that the Recalling Firm may acknowledge their receipt of this notification per FDA requirements and subsequently process their product replacement. For any questions or assistance contact: North American Regional Complaint Center 1-84BD-LIFE (1-844-823-5433) Say Recall when prompted MonFri 8:00am and 5:00pm CT
Quantity in commerce: 100 units
Distribution: U.S.: TN O.U.S.: None
Product codes and lots: Catalog Number:MP9246-C GTIN: 10885403237157 Lot Number: 20087194

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1995-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1995-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-07	2021-07-01

Product code FPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)