Recall Z-1301-2020 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
| Date | Feb 4, 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 | Other |
| Action | Urgent Medical Device Correction 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 packs and lot numbers per enclosed report identifying your facilitys packs. 2. ALERT your clinicians of this action including Exhibit A and B. 3. SEGREGATE and QUARANTINE all Presource Procedure Packs on-hand that are confirmed to be affected by lot number, if not already completed, per enclosed report identifying your facilitys packs. 4. AFFIX a WARNING LABEL as outlined in Exhibit A and |
| Quantity | 318,000 units |
| Distribution | US Nationwide. Chile, Israel, UAE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.