MaxPlus, MaxGuard recallZ-1995-2021 · Carefusion · initiated Jun 9, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Carefusion or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Under Investigation by firm
What the company is doing
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
Recall details
- Recall number
- Z-1995-2021
- Status
- Terminated
- Initiated by the company
- Jun 9, 2021
- Recalling firm
- Carefusion
- Quantity
- 100 units
- Product code
- FPA
- Distribution
- U.S.: TN O.U.S.: None
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.
Code information (models, lots, serial numbers)
Catalog Number:MP9246-C GTIN: 10885403237157 Lot Number: 20087194
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MaxPlus, MaxGuard MP9246-CBD Switzerland Sàrl · Set, administration, intravascular1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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