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Recall Observatory FDA recall evidence

Device product

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

Z-1804-2024

March 19, 2024

Class II

Product summary

Firm
Medtronic Perfusion Systems
Event
Event 94274
Status
Ongoing
Classification
Class II
Quantity
13198 units
Official record key
device-enforcement:Z-1804-2024

Official wording

Reason: Potential for unsealed sterile packing.

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

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for unsealed sterile packing.