The Recall Desk
HighFDA (Devices)·Z-1804-2024·Announced 2024-05-22

Medtronic Suction Tubes Recalled for Potential Unsealed Sterile Packaging

Medtronic is recalling multiple models of suction tubes due to potential for unsealed sterile packing, which could compromise device sterility. Affected customers should refer to the official FDA recall notice for lot details.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This Class II recall involves potential sterility compromise of a medical device. Per the severity rubric, risk-of-harm products where injury has not been reported score as High (3). The unsealed packaging creates a potential contamination risk during sterile medical use.

Plain-English summary

Medtronic Perfusion Systems is recalling multiple models of DLP suction tubes used in medical and surgical procedures. The recall addresses a potential for unsealed sterile packing, which may compromise the sterility of these medical devices.

The affected products include five models: 6-Fr. Shaft with Frazier Tip (Model 10050), 6-Fr. Shaft with 10-Fr. Soft Tip (Models 10052 and 10053), 10-Fr. Shaft with 20-Fr. Pool Tip (Model 10060), and 16-Fr. Shaft with 20-Fr. Fluted Tip (Model 10061). Approximately 13,198 units were distributed worldwide. Specific lot numbers have been identified for each model and are available in the recall notice.

Healthcare facilities and practitioners who have used or may have in inventory any of the affected lot numbers should refer to the official FDA recall notice (Z-1804-2024) for detailed lot information and guidance on next steps.

The recalled product

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
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Surgical / Suction Devices
Hazard
Affected units
13,198

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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
  • GTIN 00763000860820
  • Lot Numbers: 2023040913
  • 2023041284

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 13 recalled by Medtronic Perfusion Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

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