Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,

FDA device recall Z-0887-2026 · posted 2025-12-05 · Open, Classified

Recall details

Recalling firm

Bard Peripheral Vascular Inc

Reason for recall

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.

Action taken

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

Root cause

Process control

Status

Open, Classified

Product code

PXI

Quantity affected

1240

Distribution

US Nationwide distribution in the states of CA, MN, IN, MI, LA.

Date initiated

2025-11-06

Date posted

2025-12-05

Location

Tempe, AZ