Z-1804-2024 Class II Ongoing
FDA device recall Z-1804-2024 was initiated by Medtronic Perfusion Systems on Mar 19, 2024 and is designated Class II. Reason for recall: Potential for unsealed sterile packing. The recall status is ongoing. Affected quantity: 13198 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2024
- Initiation Date
- Mar 19, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13198 units
Product Description
Medtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 10050, b) DLP¿ Suction Tube 6-Fr. Shaft with 10-Fr. Soft Tip, Model Number: 10052, c) DLP¿ Suction Tube 6-Fr. Shaft with 10-Fr. Soft Tip, Model Number: 10053, d) DLP¿ Suction Tube 10 Fr. Shaft with 20 Fr. Pool Tip, Model Number: 10060, e) DLP¿ Suction Tube 16 Fr. Shaft with 20 Fr. Fluted Tip, Model Number: 10061
Reason for Recall
Potential for unsealed sterile packing.
Distribution Pattern
Worldwide distribution.
Code Information
a) Model Number: 10050, GTIN 20613994698272, Lot Numbers: 2023041269; b) Model Number: 10052, GTIN 20613994698319, Lot Numbers: 2023041270, 202305C072; c) Model Number: 10053, GTIN 20613994698333, Lot Numbers: 2023041271, 202305C071; d) Model Number: 10060, GTIN 20613994570448, Lot Numbers: 2023041164; e) Model Number: 10061, GTIN 00613994570468, Lot Numbers: 2023041284; e) Model Number: 10061, GTIN 00763000860820, Lot Numbers: 2023040913, 2023041284; e) Model Number: 10061, GTIN 20613994570462, Lot Numbers: 2023040913, 2023040914, 2023041273, 2023041274, 2023041275, 2023041277, 2023041278, 2023041279, 2023041281, 2023041282, 2023041284, 2023041285, 202305C056, 202305C057
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1804-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026