Medtronic Suction Tubes: a) DLP Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 10050, b) DLP Suction Tube 6-Fr
FDA device recall Z-1804-2024 · posted 2024-05-10 · Open, Classified
Recall details
- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- Potential for unsealed sterile packing.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- DTS
- Quantity affected
- 13198 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2024-03-19
- Date posted
- 2024-05-10
- Location
- Brooklyn Park, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.