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High RiskFDAfda-Z-1300-2014OTHER

PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 171600...

Units Affected
777
Recall Date
February 27, 2014
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1300-2014.

Labeling discrepancy.The label states that the implantable port contains silicone suture plugs, however approximately 23% of the units contained in the affected lots have a PowerPort Slim titanium implantable port without silicone suture plugs.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1300-2014.

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 Access Systems 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-1300-2014.

Bard Access Systems

FDA

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Bard Access Systems Recall FAQ

Bard Access Systems is the subject of a medical implants safety report: PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 171600.... The notice was published on February 27, 2014 by the U.S. Food and Drug Administration (FDA). Approximately 777 units are potentially affected.