FDAFDA · Food and drugs·Recall number Z-0244-2019
CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 ) Product Number:-D36-14623
Published October 31, 2018 · Recall initiated: August 13, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Custom Healthcare Systems, Inc.
- Distributor
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- Lot
- Lot number: 52418 Exp. Date: 5/1/2021
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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