Recall Z-0265-2019 ยท LRO General Surgery Tray
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL 1231-150XL GOWN, SURGICAL XXL
| Date | Aug 13, 2018 |
| Status | Terminated |
| Reason | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility |
| Root cause | Packaging |
| Action | Custom Healthcare Systems (CHS) initiated recall by phone, email and by certified mail on 8/13/18 and carried out to the end user. Custom Healthcare Systems Inc. notified the customers, they were informed to contact their account to receive the product. Product to be returned and credited. |
| Quantity | 89 units |
| Distribution | Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.