—#189291

Product

Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K190557
Affected lot / code info: Model 96553 - Serial number 220719040, GTIN 20763000116006; Model 96551 - Serial number 220641720, GTIN 20763000115986.

Why it was recalled

There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Medtronic Perfusion Systems
Address: 7611 Northland Dr N, Brooklyn Park, Minnesota 55428-1088

Distribution

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.

Timeline

Recall initiated: 2021-09-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #189291. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.