FDA Medical Device Recalls (openFDA)
Bard Peripheral Vascular Inc: Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T
- Recall number
- Z-0887-2026
- Recalling firm
- Bard Peripheral Vascular Inc
- Product
- Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
- Status
- Open, Classified
- Initiated
- 2025-11-06
- Posted
- 2025-12-05
- Terminated
- not on file
- 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.
- 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 BDRC28@bd.com Affected product complaints can be reported via email: productcomplaints@bd.com
- Quantity
- 1240
- Distribution
- US Nationwide distribution in the states of CA, MN, IN, MI, LA.
- Lot, serial or model codes
- UDI/Lot/Expiration: (01)10885403108365(17)271130(10)0001623320/0001623320/20271130; (01)10885403108365(17)271130 (10)0001623069/0001623069/20271130
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PXI
- Firm FEI
- 2020394
- Firm city
- Tempe
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28