Recall Z-1235-2020 ยท LRO General Surgery Tray
Cardinal Health 200, LLC
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
| Date | Feb 3, 2020 (initiated Jan 31, 2020) |
| Status | Terminated |
| Reason | The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. |
| Root cause | Vendor change control |
| Action | Urgent Medical Device Recall notification letters dated 1/31/20 were distributed to customers. Actions Required: 1. CHECK all storage and usage locations to confirm if you have any units of the affected item codes and lot numbers in your possession per enclosed report identifying your facilitys packs. Exhibit A outlines how to identify affected packs and the lot number. 2. SEGREGATE and QUARANTINE all packs on-hand that are confirmed to be affected by lot number per attached report identifying your facilitys packs. 3. RETURN the enclosed acknowledgment form either by facsimile (614-495-5651) |
| Quantity | 2,161,526 units (113, 711 additional units as of 2/25/20) |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.