Hyalomatrix recalled over laceration hazard

Recall date

May 10, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Anika Therapeutics, Inc. recalls Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered, sterile, flexi…

Recall number

Z-2423-2018

FDA classification

Class II

Brand / firm

Anika Therapeutics, Inc.

Sold / distributed

US Nationwide Distribution in the state of IL.

Why it was recalled

Hyalomatrix products are susceptible to degradation as a result of the decomposition of PVC in the packaging material during sterilization, which resulted in degradation of the film. Over the long term it is possible that product integrity may be compromised.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered, sterile, flexible, and comfortable wound dressing that acts as an advanced wound care device. It is comprised of a non-woven pad entirely composed of HY AFF 11, a benzyl ester of hyaluronic acid, and a semipermeable silicone membrane, which controls water vapor loss, provides a flexible covering for the wound surface, and adds increased tear strength to the device. The HYAFFl 1 wound contact layer biodegradable matrix acts as a scaffold for cellular invasion and capillary growth. Hyalomatrix is indicated for the management of wounds including: partial and full-thickness wounds; second-degree bums; pressure ulcers; venous ulcers; diabetic ulcers; chronic vascular ulcers; tunneled/undetermined wounds; surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence); trauma wounds (abrasions, lacerations, skin tears); and draining wounds. The device is intended for one-time use.