Recall Z-0887-2026 ยท PXI Thoracentesis Tray
Bard Peripheral Vascular Inc
Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
| Date | Dec 5, 2025 (initiated Nov 6, 2025) |
| Status | Open, Classified |
| Reason | Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels. |
| Root cause | Process control |
| Action | On 11/06/2025, Medical Device Product Removal Notices were mailed to Health Care Professionals (HCPs), Risk Managers, Head Nurses, Nurse Managers, Medical Device Safety Officers, Procurement Officers, and Office Managers informing them of the following: Discontinue use of product listed in the letter and immediately dispose of all affected product remaining in your possession in accordance with your local facility's process. Share this notification with all users within your facility network of the product to ensure they are also aware of this field action. If the affected products have been |
| Quantity | 1240 |
| Distribution | US Nationwide distribution in the states of CA, MN, IN, MI, LA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.