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.
This recall has been terminated (originally issued June 9, 2021).
- Company
- Carefusion
- Recall Initiated
- June 9, 2021
- Terminated
- July 8, 2024
- Recall Number
- Z-1995-2021
- Quantity
- 100 units
- Firm Location
- San Diego, CA
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Catalog Number:MP9246-C GTIN: 10885403237157 Lot Number: 20087194
Root Cause
Under Investigation by firm
Action Taken
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