FDA-Device2018-10-31Class II
CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112
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
4500 units
Manufactured in
4205 Eubank Rd, N/A, Richmond, VA, United States
Products
CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0267-2019Don't want to check this manually?
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