Recall Z-3016-2020 ยท LRP Tray, Surgical
Cardinal Health 200, LLC
KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.
| Date | Jul 30, 2020 |
| Status | Terminated |
| Reason | Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment. |
| Root cause | Employee error |
| Action | On July 30th the firm send its consignee a letter notifying them of the field action. Component Part Number: X12048 (SWABSTICK, PVP-I,10%, NASAL DECOLONIZATION, PROFEND,NS) is supplied to Cardinal Health, Presource in a package of 4 nasal swabs. Per the suppliers Instructions for Use, X12048 is a kit that needs to be administered in a 4-swab treatment with two swabs used per nasal passage. Presource is only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment. The Presource kit was set up requiring 1 each of the swab component, but confusion in the c |
| Quantity | 9,150 kits |
| Distribution | US Nationwide distribution including the state of North Carolina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.