FDA-Device2018-10-31Class II
(1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product Code: D36-16269
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
(1) 180 units (2)180 units
Manufactured in
4205 Eubank Rd, N/A, Richmond, VA, United States
Products
(1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product Code: D36-16269
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0249-2019Don't want to check this manually?
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