FDA-Device2018-10-31Class II
CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669
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
50 units
Manufactured in
4205 Eubank Rd, N/A, Richmond, VA, United States
Products
CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0256-2019Don't want to check this manually?
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