KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.
Recall
- Recall Number
- Z-3016-2020
- Event Number
- 86178
- Firm
- Cardinal Health 200, LLC
- FEI Number
- 3002973487
- Product Code
- LRP
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- July 30, 2020
- Terminated
- April 28, 2021
- Address
- 785 Fort Mill Hwy, Fort Mill, SC, 29707-7555
Description
KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.
Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.
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 component set-up caused 1 swab to be kitted instead of 1 package of 4 swabs.
US Nationwide distribution including the state of North Carolina.
9,150 kits