PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: December 17, 2025 Initiated: November 6, 2025 #Z-0887-2026

Product Description

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

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.

Details

Units Affected
1240
Distribution
US Nationwide distribution in the states of CA, MN, IN, MI, LA.
Location
Tempe, AZ

Frequently Asked Questions

What product was recalled?
Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,. Recalled by Bard Peripheral Vascular Inc. Units affected: 1240.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 17, 2025. Severity: Moderate. Recall number: Z-0887-2026.