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High RiskFDAfda-Z-0960-2019OTHER

PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with intervention...

Units Affected
26
Recall Date
July 3, 2018
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0960-2019.

Incorrect expiration being entered for one lot.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0960-2019.

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 Abbott Vascular 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-0960-2019.

Abbott Vascular

FDA

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Abbott Vascular Recall FAQ

Abbott Vascular is the subject of a medical implants safety report: PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with intervention.... The notice was published on July 3, 2018 by the U.S. Food and Drug Administration (FDA). Approximately 26 units are potentially affected.