—#209609

Product

Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K120988
Affected lot / code info: GTIN 20613994879329, Lot Numbers: 2023090954, 202312C065

Why it was recalled

During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312).

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medtronic issued an Urgent: Medical Device Recall notice to its consignees on 07/09/2024 via UPS. The notice explained the issue, potential risk, and requested return of the affected device. Those who further distributed the device were directed to share the notice with those to whom the affected product was distributed.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Cambodia, Greece, Ireland, Italy, Saudi Arabia, Switzerland, United Kingdom, Viet Nam.

Timeline

Recall initiated: 2024-07-09
Posted by FDA: 2024-09-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209609. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.