The Baxter Vascular Patch for peripheral vascular reconstruction is involved in a product recall.
A FDA Class I recall is “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
Customers have complained to Baxter about the difficulty in deciphering the smooth from rough surface on the Vascu-Guard patch. They are saying the labeled instructions are hard to distinguish the difference between the surface texture in the new packaging.
If the patch is applied incorrectly, patients may face an increased risk of vessel thrombosis or embolism, possibly both. Thromboses may cause heart attacks, strokes, and blood clots. You should speak to your doctor with any medical concerns or questions.
According to the FDA, four product codes affected by this Class I recall notice:
- 1504026 VASCU-GUARD TS 1x6cm
- 1504028 VASCU-GUARD TS 0.8x8cm
- 1504030 VASCU-GUARD TS 1x10cm
- 1504032 VASCU-GUARD TS 2x9cm
Zoll & Kranz, LLC (ZK Law) is a product liability / mass tort law firm advocating for plaintiffs injured by dangerous drugs and medical devices. ZK Law provides a free case evaluation if you believe you have been injured by this drug or other pharmaceutical. To speak with one of our recalled device attorneys, call toll-free (888) 841-9623.