FDA recall Z-0887-2026

Bard Peripheral Vascular Inc · Class II · device

Product

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-11-06
Report date
2025-12-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tempe, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0887-2026