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Custom Healthcare Systems, Inc. recalls (1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGIN
Recalled October 31, 2018 · FDA recall Z-0249-2019 · Custom Healthcare Systems
Hazard
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility · FDA Class II
Units
(1) 180 units (2)180 units
Sold at
Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
Description
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Product
(1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product Code: D36-16269
Manufacturer(s)
Custom Healthcare Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →