Recall Z-1925-2020 ยท MMP Cover, Barrier, Protective
Stryker Corporation
Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282
| Date | Jan 7, 2020 |
| Status | Open, Classified |
| Reason | Sterile drapes packaged in an unsealed pouch. |
| Root cause | Under Investigation by firm |
| Action | An URGENT MEDICAL DEVICE RECALL NOTIFICATION letter was sent to the affected customers on 01/07/2020 informing them of the product field action prompting them to send any unused affected units back to the manufacturer. |
| Quantity | 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, Malay |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162885 | SPY Phi Open Field Handheld Fluorescence Imaging System Novadaq Technologies, Inc., Jan 11, 2017 |