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U.S. Department of Health and Human Services

Class 2 Device Recall KIT, PRE OP DRAH

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 Class 2 Device Recall KIT, PRE OP DRAHsee related information
Date Initiated by FirmJuly 30, 2020
Create DateSeptember 25, 2020
Recall Status1 Terminated 3 on April 28, 2021
Recall NumberZ-3016-2020
Recall Event ID 86178
Product Classification Tray, surgical - Product Code LRP
ProductKIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.
Code Information Model: ORPDH5994A Lot numbers: 558357, 561502,566549, 571467, 574058.  Expiration dates: Varies by kit components.
FEI Number 3002973487
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
785 Fort Mill Hwy
Fort Mill SC 29707-7555
For Additional Information ContactJosh Diercks
803-802-6800
Manufacturer Reason
for Recall		Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.
FDA Determined
Cause 2		Employee error
ActionOn 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.
Quantity in Commerce9,150 kits
DistributionUS Nationwide distribution including the state of North Carolina.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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