CAREFUSION 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
CAREFUSION
Lot Codes / Batch Numbers
Catalog Number:MP9246-C GTIN: 10885403237157 Lot Number: 20087194
Products Sold
Catalog Number:MP9246-C GTIN: 10885403237157 Lot Number: 20087194
CAREFUSION is recalling MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless due to A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.
Recommended Action
Per FDA guidance
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: BDRC9@bd.com, 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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
TN
Page updated: Jan 10, 2026