Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282
Reported: May 13, 2020 Initiated: January 7, 2020 #Z-1925-2020
Product Description
Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282
Reason for Recall
Sterile drapes packaged in an unsealed pouch.
Details
- Recalling Firm
- Stryker Corporation
- Units Affected
- 26,298 units
- Distribution
- 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, Malaysia, Finland, Denmark, Israel, Qatar, Kazakhstan, Turkey, Czech Republic, Greece, Russia, Poland, Ireland, Philippines, and New Zealand.
- Location
- San Jose, CA
Frequently Asked Questions
What product was recalled? ▼
Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282. Recalled by Stryker Corporation. Units affected: 26,298 units.
Why was this product recalled? ▼
Sterile drapes packaged in an unsealed pouch.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 13, 2020. Severity: Moderate. Recall number: Z-1925-2020.
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