510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-1804-2024Class II

Medtronic Suction Tubes: a) DLP Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 10050, b) DLP...

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 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... 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-1804-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Medtronic Perfusion Systems
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
Product code
DTS Sucker, Cardiotomy Return, 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
13198 units
Distribution
Worldwide distribution.
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1804-2024
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