Cardinal Health 200, LLC KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.
Brand
Cardinal Health 200, LLC
Lot Codes / Batch Numbers
Model: ORPDH5994A Lot numbers: 558357, 561502, 566549, 571467, 574058. Expiration dates: Varies by kit components.
Products Sold
Model: ORPDH5994A Lot numbers: 558357, 561502,566549, 571467, 574058. Expiration dates: Varies by kit components.
Cardinal Health 200, LLC is recalling KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus. due to Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026