Recall Z-0887-2026— Bard Peripheral Vascular Inc
Class II · Ongoing
Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2025-11-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,. Reason: 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..
- Recalling firm
- Bard Peripheral Vascular Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-11-06
- Firm location
- Tempe, AZ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.