Z-1081-2021Class II

ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K

Name: Z-1081-2021 ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K
Creator: Cardinal Health 200, LLC
Published: 2021-01-07
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-01-07 / Terminated

FDA source

Cardinal Health 200, LLC began a recall of ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K on 2021-01-07. FDA classified it as Class II and gives the reason as "Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1081-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-07
Posted: 2021-02-05
Terminated: 2024-02-14
Recalling firm: Medtronic, Inc.
Product: ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K
Product code: LYU Accessory, Surgical Apparel
Reason for recall: Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
FDA 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 [email protected], 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: [email protected] or call 800-292-9332.
Quantity in commerce: 137,346 kits
Distribution: Global Distribution. US Nationwide.
Product codes and lots: Lots: 915019X 915020X 915021X 915022X 924422X 925174X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1081-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1078-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-05
Z-1079-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-05
Z-1080-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-05
Z-1081-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-05
Z-1082-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-05
Z-1083-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-05

Product code LYU

K002064Class IComfit Chemo Plus Powder Free Blue Nitrile Examination Gloves, Non Sterile (Tested for Use with Chemotherapy Drug) LabelWrp Asia Pacific Sdn. Bhd. / cleared 2000-11-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)