Bard Peripheral Vascular Inc recalls Safe-T-Centesis 6 Fr Catheter Drainage 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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Safe-T-Centesis 6 Fr Catheter Drainage Tray1 code
- PIG1260T
Lot / code information
UDI/Lot/Expiration: (01)10885403108365(17)271130(10)0001623320/0001623320/20271130; (01)10885403108365(17)271130 (10)0001623069/0001623069/20271130
What the firm is doing
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
DistributionShow detailsHide
US Nationwide distribution in the states of CA, MN, IN, MI, LA.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0887-2026
- FDA device classification · PXIOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.5570The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Bard Peripheral Vascular IncSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class II recalls
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems S…
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…
- Pneumatic Tourniquet
- Under Investigation by firm
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems D…
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…
- Pneumatic Tourniquet
- Under Investigation by firm
W L Gore & Associates, Inc. recalls GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Re…
Due to catheter separation
- Aortic Aneurysm Treatment Endovascular Graft System
- Under Investigation by firm
