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High RiskFDAfda-Z-1551-2021CHOKING

PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829570, UDI: (01) 008...

Units Affected
189
Recall Date
March 25, 2021
Issuing Agency
Hazard
Choking

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1551-2021.

Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1551-2021.

Recall terminated by FDA.

✅ What you should do

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. Contact Bard Peripheral Vascular Inc or the retailer where you bought it for a refund, replacement, or repair.
  4. For the most current official instructions, visit the FDA recall page.
  5. If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1551-2021.

Bard Peripheral Vascular Inc

FDA

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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.

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Bard Peripheral Vascular Inc Recall FAQ

Bard Peripheral Vascular Inc is the subject of a medical implants safety report: PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829570, UDI: (01) 008.... The notice was published on March 25, 2021 by the U.S. Food and Drug Administration (FDA). Approximately 189 units are potentially affected.