Safe-T-Centesis recallZ-0887-2026 · Bard Peripheral Vascular Inc · initiated Nov 6, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bard Peripheral Vascular Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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 distributed further, please ensure that these entities are contacted and informed of the recall. If you purchased this product from a distributor, contact your distributor for further instructions and product resolution. Complete and return the attached Customer Response Form and return via email to [email protected] Affected product complaints can be reported via email: [email protected]
Recall details
- Recall number
- Z-0887-2026
- Status
- Open, Classified
- Initiated by the company
- Nov 6, 2025
- Posted by the FDA
- Dec 5, 2025
- Recalling firm
- Bard Peripheral Vascular Inc
- Quantity
- 1240
- Product code
- PXI
- Distribution
- US Nationwide distribution in the states of CA, MN, IN, MI, LA.
Product description
Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
Code information (models, lots, serial numbers)
UDI/Lot/Expiration: (01)10885403108365(17)271130(10)0001623320/0001623320/20271130; (01)10885403108365(17)271130 (10)0001623069/0001623069/20271130
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Safe-T-Centesis PIG1260TCarefusion 2200, Inc · Thoracentesis tray2 recalls27 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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