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Terminated

KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.

FDA Recall Z-3016-2020 · Posted None

Recalling FirmCardinal Health 200, LLC
Recall StatusTerminated
Product CodeLRP
Date Initiated2020-07-30
Date Terminated2021-04-28
Product Quantity9,150 kits

Reason for Recall

Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.

Firm 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 component set-up caused 1 swab to be kitted instead of 1 package of 4 swabs.

Root Cause

Employee error

Distribution Pattern

US Nationwide distribution including the state of North Carolina.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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