FDA Medical Device Recalls (openFDA)
Cardinal Health 200, LLC: KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.
- Recall number
- Z-3016-2020
- Recalling firm
- Cardinal Health 200, LLC
- Product
- KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.
- Status
- Terminated
- Initiated
- 2020-07-30
- Posted
- not on file
- Terminated
- 2021-04-28
- Reason
- Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.
- Root cause
- Employee error
- 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.
- Quantity
- 9,150 kits
- Distribution
- US Nationwide distribution including the state of North Carolina.
- Lot, serial or model codes
- Model: ORPDH5994A Lot numbers: 558357, 561502,566549, 571467, 574058. Expiration dates: Varies by kit components.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRP
- Firm FEI
- 3002973487
- Firm city
- Fort Mill
- Firm state
- SC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28