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High RiskFDAfda-Z-1703-2016OTHER

WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Nu...

Units Affected
5,980
Recall Date
April 26, 2016
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1703-2016.

Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1703-2016.

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 B. Braun Medical, 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-1703-2016.

B. Braun Medical, Inc.

FDA

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B. Braun Medical, Inc. Recall FAQ

B. Braun Medical, Inc. is the subject of a medical implants safety report: WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Nu.... The notice was published on April 26, 2016 by the U.S. Food and Drug Administration (FDA). Approximately 5,980 units are potentially affected.