Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T, (Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy. Tempe AZ 85281-2438) – laceration hazard (2025)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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 BDRC28@bd.com Affected product complaints can be reported via email: productcomplaints@bd.com