Z-0887-2026Class II

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

Name: Z-0887-2026 Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T
Creator: Bard Peripheral Vascular Inc
Published: 2025-11-06
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2025-11-06 / Open, Classified / root cause: manufacturing process

FDA source

Bard Peripheral Vascular Inc began a recall of Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T on 2025-11-06. FDA classified it as Class II and gives the reason 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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0887-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-06
Posted: 2025-12-05
Recalling firm: Bard Peripheral Vascular Inc
Product: Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
Product code: PXI Thoracentesis Tray
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 11/06/2025, Medical Device Product Removal Notices were mailed to Health Care Professionals (HCPs), Risk Managers, Head Nurses, Nurse Managers, Medical Device Safety Officers, Procurement Officers, and Office Managers informing them of the following: Discontinue use of product listed in the letter and immediately dispose of all affected product remaining in your possession in accordance with your local facility's process. Share this notification with all users within your facility network of the product to ensure they are also aware of this field action. If the affected products have been distributed further, please ensure that these entities are contacted and informed of the recall. If you purchased this product from a distributor, contact your distributor for further instructions and product resolution. Complete and return the attached Customer Response Form and return via email to [email protected] Affected product complaints can be reported via email: [email protected]
Quantity in commerce: 1240
Distribution: US Nationwide distribution in the states of CA, MN, IN, MI, LA.
Product codes and lots: UDI/Lot/Expiration: (01)10885403108365(17)271130(10)0001623320/0001623320/20271130; (01)10885403108365(17)271130 (10)0001623069/0001623069/20271130

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0887-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0887-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-17	2025-12-05

Product code PXI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)