Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009,
Summary
The FDA issued a Class II for Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Ext by Medtronic Perfusion Systems. Reason: Potential for unsealed sterile packing..
Details
Source
Device Recall
External ID
Z-1801-2024
Action Date
2024-05-22
Status
Ongoing
Category
device
Product Description
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
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
Quantity Affected: 6290 units
Reason for Recall
Potential for unsealed sterile packing.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-19
Company
Brooklyn Park, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 191 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Perfusion Systems has 50 FDA actions in our database, including 49 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Perfusion Systems) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Perfusion Systems have FDA actions?
Medtronic Perfusion Systems has 50 FDA actions in our database, including 49 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1801-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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