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

Recall Z-2135-2014 — Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. Product Usage: Expression is labelled as an Intranasal Splint, intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity

U.S. FDA — Device Enforcement · United States · 2013-08-07 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2135-2014
Date of alert: 2013-08-07
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Enhancement Medical, LLC
Product category: device
Product type: Devices

Reported risk: Manufacturer made a change in the production process that resulted in a change in final gel weight. RECALL EXPANDED 7/8/2014 Firm expanded their recall to include all lots of product.

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.

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