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U.S. Department of Health and Human Services

Class 2 Device Recall MaxPlusTM bi fuse extension set with 2 clear needleless connectors

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  Class 2 Device Recall MaxPlusTM bi fuse extension set with 2 clear needleless connectors see related information
Date Initiated by Firm June 09, 2021
Create Date July 01, 2021
Recall Status1 Open3, Classified
Recall Number Z-1995-2021
Recall Event ID 88104
Product Classification Set, administration, intravascular - Product Code FPA
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.
Code Information Catalog Number:MP9246-C GTIN: 10885403237157 Lot Number: 20087194
Recalling Firm/
Manufacturer
CAREFUSION
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
For Additional Information Contact
844-823-5433
Manufacturer 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 Determined
Cause 2
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: 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
Quantity in Commerce 100 units
Distribution U.S.: TN O.U.S.: None
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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