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High RiskFDAfda-Z-2103-2015STERILITY ISSUE

Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implan...

Units Affected
167
Recall Date
June 18, 2015
Issuing Agency
Hazard
Sterility Issue

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2103-2015.

Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2103-2015.

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 Allergan 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-2103-2015.

Allergan Inc

FDA

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Allergan Inc Recall FAQ

Allergan Inc is the subject of a medical implants safety report: Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implan.... The notice was published on June 18, 2015 by the U.S. Food and Drug Administration (FDA). Approximately 167 units are potentially affected.