Recall Z-1804-2024— Medtronic Perfusion Systems
Class II · Ongoing
Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2024-03-19. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Potential for unsealed sterile packing..
- Recalling firm
- Medtronic Perfusion Systems
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-19
- Firm location
- Brooklyn Park, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.