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Bard Peripheral Vascular Inc: Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,

Medical DevicesSource: FDA (device) · Date: 2025-12-17

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Bard Peripheral Vascular Inc
Product
Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of CA, MN, IN, MI, LA.
Recall initiated
2025-11-06
Code info
UDI/Lot/Expiration: (01)10885403108365(17)271130(10)0001623320/0001623320/20271130; (01)10885403108365(17)271130 (10)0001623069/0001623069/20271130
Product quantity
1240
Voluntary mandated
Voluntary: Firm initiated
City
Tempe
State
AZ
Country
United States
Event id
97864
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