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High RiskFDAfda-Z-2334-2017STERILITY ISSUE

1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lumen catheter perm...

Units Affected
27,485
Recall Date
May 9, 2017
Issuing Agency
Hazard
Sterility Issue

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2334-2017.

Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2334-2017.

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 Arrow International 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-2334-2017.

Arrow International Inc

FDA

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The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.

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📣 Report a food, supplement, or cosmetic problem to the FDA

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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Arrow International Inc Recall FAQ

Arrow International Inc is the subject of a medical implants safety report: 1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lumen catheter perm.... The notice was published on May 9, 2017 by the U.S. Food and Drug Administration (FDA). Approximately 27,485 units are potentially affected.