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U.S. Department of Health and Human Services

Class 2 Device Recall SafeTCentesis" 6 Fr Catheter Drainage Tray

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 Class 2 Device Recall SafeTCentesis" 6 Fr Catheter Drainage Traysee related information
Date Initiated by FirmNovember 06, 2025
Date PostedDecember 05, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0887-2026
Recall Event ID 97864
Product Classification Thoracentesis tray - Product Code PXI
ProductSafe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
Code Information UDI/Lot/Expiration: (01)10885403108365(17)271130(10)0001623320/0001623320/20271130; (01)10885403108365(17)271130 (10)0001623069/0001623069/20271130
FEI Number 2020394
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
850 W. Rio Salado Prkwy.
Tempe AZ 85281-2438
For Additional Information Contact
480-303-2602
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOn 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 in Commerce1240
DistributionUS Nationwide distribution in the states of CA, MN, IN, MI, LA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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