Recall Z-1926-2020 ยท MMP Cover, Barrier, Protective
Stryker Corporation
Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI: HH2020/20858701006326
| 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 | 21,078 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
| K041501 | GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS Guangzhou Fortunique , Ltd., Nov 30, 2004 |