FDA-Device2018-10-31Class II
CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481B
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
1250 units
Manufactured in
4205 Eubank Rd, N/A, Richmond, VA, United States
Products
CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0259-2019Don't want to check this manually?
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