FDA-Device2018-10-31Class II

CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201

Custom Healthcare Systems, Inc.
Hazard

Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility

Sold states
Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
Affected count
40 units
Manufactured in
4205 Eubank Rd, N/A, Richmond, VA, United States
Products
CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0241-2019

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