—#206800

Product

Medtronic Disposable Pressure Display Sets: a) DLP 114.3 cm (45 in), Model Number 61000; b) DLP 114.3 cm (45 in), Model Number 62000

FDA product code: DXS — Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K113235
Affected lot / code info: a) Model Number 61000, GTIN 00643169880955, Lot Numbers: 2023030432, 2023030433; a) Model Number 61000, GTIN 20643169880959, Lot Numbers: 2023030431, 2023030432, 2023030433, 2023030734, 202305C226, 202307C176, 202307C177; b) Model Number 62000, GTIN 20613994846642, Lot Numbers: 2023030223, 2023030736, 2023031580, 202305C225

Why it was recalled

Potential for unsealed sterile packing.

Root cause (FDA determination)

Process control

Action the firm took

Medtronic issued an Urgent Medical Device Recall notice to its consignees on 03/19/2024 via letter (UPS). The notice explained the issue, potential risk, and requested the consignee identify and return the product. Consignee was directed to forward the notice to all affected parties. For questions, the consignee was directed to contact their Medtronic field representative.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2024-03-19
Posted by FDA: 2024-05-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206800. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.