FDA Medical devices recall ·
Safe-T-Centesis 6 Fr Catheter Drainage Tray recall
- Recall number
- Z-0887-2026
- Date
- (initiated November 6, 2025)
- Company / brand
- Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1, Tempe, AZ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1240
- Hazard tags
- Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/Lot/Expiration: (01)10885403108365(17)271130(10)0001623320/0001623320/20271130; (01)10885403108365(17)271130 (10)0001623069/0001623069/20271130
Distribution
US Nationwide distribution in the states of CA, MN, IN, MI, LA.
States: California Indiana Louisiana Michigan Minnesota
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0887-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.