Recalls / —

—#182958

Product

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

FDA product code

LRP — Tray, Surgical

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

Model: ORPDH5994A Lot numbers: 558357, 561502,566549, 571467, 574058.  Expiration dates: Varies by kit components.

Why it was recalled

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

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm

Cardinal Health 200, LLC

Address

785 Fort Mill Hwy, Fort Mill, South Carolina 29707-7555

Distribution

Distribution pattern

US Nationwide distribution including the state of North Carolina.

Timeline

Recall initiated

2020-07-30

Terminated

2021-04-28

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #182958. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.