Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2103-2015 — Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.

U.S. FDA — Device Enforcement · United States · 2015-06-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2103-2015
Date of alert: 2015-06-18
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Allergan Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 11250691

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-2103-2015 — Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.

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