Medical device recalls Moderate risk

Stryker Corporation recalls Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/…

Recall date
January 7, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1925-2020
FDA classification
Class II
Brand / firm
Stryker Corporation
Sold / distributed
US - Nationwide & Puerto Rico OUS - Netherlands, Spain, Switzerland, Colombia, Canada, Japan, Taiwan, Puerto Rico, South Africa, South Korea, Australia, Chile, China, Germany, France, United Kingdom, Hong Kong, India, Italy, Singapore, Thailand, Romania, Belgium, Sweden, Switzerland, Austria, Malay…

Why it was recalled

Sterile drapes packaged in an unsealed pouch.

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

What was recalled

Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282

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