medical Class II Updated 2018-10-31

Custom Healthcare Systems, Inc. recalls (1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Pro

Recalled Product

(1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product Code: D36-16269


Hazard / Issue

Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility

Issued by

FDA

Distribution: Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
Lot/Code Info: (1)Lot number: 52418, 51418 Exp. Date: 5/1/2021 (2) Lot Number:51418 Exp Date: 5/1/2021
View official government recall

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