—#206799

Product

Medtronic Cardioplegia Adapters: a) DLP 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009, b) DLP 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25010, c) DLP 30.5 cm (12 in) Multiple Perfusion Set, Model Number 14003, d) DLP 38.1 cm (15 in) Multiple Perfusion Set, Model Number 14000, e) DLP 50.8 cm (20 in) Extension Line Adapter, Model Number 11001G, f) DLP Perfusion/Venting Adapter, Model Number 13002, g) DLP Y Adapter Coronary Perfusion, Model Number 10710

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K182586
Affected lot / code info: a) Model Number 25009, GTIN 20613994918608, Lot Numbers: 2023040212, 202305C110; b) Model Number 25010, GTIN 20613994918585, Lot Numbers: 2023041227, 202305C111; c) Model Number 14003, GTIN 00613994619662, Lot Numbers: 2023040464; c) Model Number 14003, GTIN 20613994619666, Lot Numbers: 2023040463, 2023040464, 202305C102; d) Model Number 14000, GTIN 00613994619716, Lot Numbers: 2023041205, 2023041206; d) Model Number 14000, GTIN 20613994619710, Lot Numbers: 2023041205, 2023041206, 202305C098, 202305C099; e) Model Number 11001G, GTIN 00613994918550, Lot Numbers: 2023031005; e) Model Number 11001G, GTIN 20613994918554, Lot Numbers: 2023030371, 2023030659, 2023031004, 2023031005, 2023031530, 2023040160, 2023040431, 2023040432, 2023040804, 2023040805, 2023041171, 202306C131, 202306C136, 202308C218; f) Model Number 13002, GTIN 20613994756057, Lot Numbers: 2023040459, 202305C097; g) Model Number 10710, GTIN 20613994685937, Lot Numbers: 20613994685937

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 #206799. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.