FDA Medical Device Recalls (openFDA)
Cardinal Health 200, LLC: CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile, SKU DP5106K
- Recall number
- Z-1079-2021
- Recalling firm
- Cardinal Health 200, LLC
- Product
- CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile, SKU DP5106K
- Status
- Terminated
- Initiated
- 2021-01-07
- Posted
- not on file
- Terminated
- 2024-02-14
- Reason
- Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
- Root cause
- Process change control
- Action
- URGENT MEDICAL DEVICE CORRECTION NOTICE notification letters dated 1/7/21 were sent to customers. Actions requested on your part: 1) REVIEW your inventory for affected product. 2) QUARANTINE affected product per Attachment 1 within your inventory 3) AFFIX one WARNING LABEL included with this notification to the front of each ChemoPlus" and ChemoBloc" Chemo Spill and Preparation/Administration kits so that it is clearly visible to clinicians, instructing them to remove the affected gown component prior to use. 4) COMMUNICATE this action with all personnel the need to remove the gowns prior to use. 5) NOTIFY any customers to whom you may have distributed or forwarded affected product about this product action. 6) RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to gmb-fieldcorrectiveaction@cardinalhealth.com, whether or not you have affected product. Please contact the Customer Service group for any questions or to arrange for credit and return of any product: " Hospital800-964-5227 " Federal Government800-444-1166 " Distributor800-635-6021 " All other customers888-444-5440 For questions related to the notification, additional warning labels requests and/or acknowledgement form, please contact the market action team at: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.
- Quantity
- 137,346 kits
- Distribution
- Global Distribution. US Nationwide.
- Lot, serial or model codes
- Lot: 911609X
- 510(k) numbers
- ["K002064"]
- PMA numbers
- not on file
- Product code
- LYU
- Firm FEI
- 3001236905
- Firm city
- Waukegan
- Firm state
- IL
- 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