Medical Device Recall: Z-0003-2022

FDA Recalls dataset · Firm: Medtronic Perfusion Systems · Status: Open, Classified

Recall Action Class: N/A Date Initiated: 2021-09-13 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0003-2022.

Recall Res Number
Z-0003-2022
Recalling Firm / Manufacturer
Medtronic Perfusion Systems
FEI Number
1000116158
Recall Status
Open, Classified
Recall Classification
N/A
Date Initiated
2021-09-13
Date Posted
N/A
Date Terminated
N/A
Product Code
DWF
Event Number
88685
Product Quantity
168 kits
Product Description Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Reason for Recall There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
Action Details The recalling firm issued letters dated September 2021 beginning 9/13/2021 via 2-day UPS delivery to consignees. For outside of the United States, the recall letter will be delivered via regionally-approved methods to consignees who received the product. The letter explains the issue and requests the consignee review their inventory for the affected product. The product is to be immediately quarantined and returned after first contacting Customer Service. A Customer Confirmation Form was enclosed to be returned via email. The letter was to be shared with others within their organization as appropriate and to any other locations who have received the product through a transfer. Consignees are asked to review the Medtronic Urgent Medical Device Recall notification and follow the Recommended Actions, including quarantining and returning all unused affected Bio-Medicus Insertion Kits in their inventory.
Distribution Pattern Worldwide distribution - US Nationwide distribution in the state of Massachusetts and the countries of Belgium, France, Germany Japan, Korea, Saudi Arabia, Spain, and Turkey.
Code Information / Serial Numbers Model 96553 - Serial number 220719040, GTIN 20763000116006; Model 96551 - Serial number 220641720, GTIN 20763000115986.

Related Establishments / Registrations

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