510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-1801-2024Class II

Medtronic Cardioplegia Adapters: a) DLP 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number...

Medtronic Perfusion Systems / initiated 2024-03-19 / Open, Classified / root cause: manufacturing process
FDA source (opens on fda.gov)

Medtronic Perfusion Systems began a recall of 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... on . FDA classified it as Class II and gives the reason as "Potential for unsealed sterile packing". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1801-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Medtronic Perfusion Systems
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
Product code
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall
Potential for unsealed sterile packing.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
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.
Quantity in commerce
6290 units
Distribution
Worldwide distribution.
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1801-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1793-2024Class IIOngoingVoluntary: Firm initiated
Z-1794-2024Class IIOngoingVoluntary: Firm initiated
Z-1795-2024Class IIOngoingVoluntary: Firm initiated
Z-1796-2024Class IIOngoingVoluntary: Firm initiated
Z-1797-2024Class IIOngoingVoluntary: Firm initiated
Z-1798-2024Class IIOngoingVoluntary: Firm initiated
Z-1799-2024Class IIOngoingVoluntary: Firm initiated
Z-1800-2024Class IIOngoingVoluntary: Firm initiated
Z-1801-2024Class IIOngoingVoluntary: Firm initiated
Z-1802-2024Class IIOngoingVoluntary: Firm initiated
Z-1803-2024Class IIOngoingVoluntary: Firm initiated
Z-1804-2024Class IIOngoingVoluntary: Firm initiated
Z-1805-2024Class IIOngoingVoluntary: Firm initiated