Recall Z-0964-2019 ยท FYA Gown, Surgical
American Contract Systems, Inc.
Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the following: a. Tray Name: PACK BASIC SET UP LH - 2035102, Tray Number: LSRBASICPACD; b. Tray Name: PACK ANGIOGRAM CFH - 2071297, Tray Number: LSRCFHANGD; c. Tray Name: PACK BASIC VIII CFH - 2073903, Tray Number: LSRCFBVIIIPKE; d. Tray Name: PACK BASIC VIII CFH -2072667, Tray Number: LSRCFBVIIIPKD;
| Date | Nov 21, 2018 |
| Status | Terminated |
| Reason | Potential that product has not reached complete sterilization, |
| Root cause | Process control |
| Action | ACS notified their customer on 11/21/2018, via telephone call. The customer was questioned if they had any packs on their shelf from November 2016 through October 2017. On 12/03/2018 their customer was notified via "RECALL" letter sent via email. The letter instructed their customer to notify appropriate individuals within their organization of the recall, examine inventory for affected devices, and quarantine and discontinue use of any affected devices. The customer was also instructed to complete and return the RECALLED PRODUCT RETURN FORM via mail to: LeeSar 2727 Winkler Avenue Fort Mye |
| Quantity | 51,152 units total |
| Distribution | US Distribution is to Florida. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.