Food, drugs, devices › Bard Peripheral Vascular Inc
Device recall: Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
FDA enforcement event 97864 is a device recall by Bard Peripheral Vascular Inc of Tempe, AZ, initiated 6 Nov 2025 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Bard Peripheral Vascular Inc has 56 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Bard Peripheral Vascular Inc, Tempe, AZ.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0887-2026 | Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T, | 1240 | Class II | Ongoing | 17 Dec 2025 |
Context
Other enforcement events for Bard Peripheral Vascular Inc
All 56 events for Bard Peripheral Vascular Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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 does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of CA, MN, IN, MI, LA."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.