FDA Leans on Shelhigh

Two weeks after FDA seized Shelhigh‘s implantable devices from its Union, NJ, facility, the agency has issued a formal request for the privately held company to recall all of its products. Following the seizure, FDA asked Shelhigh to voluntarily recall its devices, but the company did not comply, causing FDA to take matters into its own hands. Now if Shelhigh chooses to refuse, FDA could issue a court order mandating the recall.

After finding “significant deficiencies” in Shelhigh’s manufacturing processes, FDA became concerned about the sterility of its products, which include pediatric heart valves and conduits, surgical patches, dural patches, annuloplasty rings and arterial grafts. “Since these are critical devices implanted into seriously-ill patients, ensuring their sterility is absolutely essential to prevent infection,” Daniel Schultz, head of FDA’s center for devices, said in a statement yesterday.

Shelhigh’s marketing director, Douglas Goldman, told The Star Ledger after the formal recall request was issued that FDA has “no information to justify any action with regard to our devices,” adding, “Our products are safe and effective and have never been demonstrated to be unsterile.”

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