Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
Summary
The FDA issued a Class II for Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T, by Bard Peripheral Vascular Inc. Reason: Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that err.
Details
Source
Device Recall
External ID
Z-0887-2026
Action Date
2025-12-17
Status
Ongoing
Category
device
Product Description
Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
Lot/Code Info: UDI/Lot/Expiration: (01)10885403108365(17)271130(10)0001623320/0001623320/20271130; (01)10885403108365(17)271130 (10)0001623069/0001623069/20271130
Quantity Affected: 1240
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-06
Company
Tempe, AZ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 244 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Bard Peripheral Vascular Inc has 42 FDA actions in our database, including 33 recalls and 9 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bard Peripheral Vascular Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bard Peripheral Vascular Inc have FDA actions?
Bard Peripheral Vascular Inc has 42 FDA actions in our database, including 33 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0887-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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