Z-1284-2019Class II

ChemoPlus Chemo Spill Kit

Name: Z-1284-2019 ChemoPlus Chemo Spill Kit
Creator: Cardinal Health 200, LLC
Published: 2019-03-22
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2019-03-22 / Terminated / root cause: manufacturing process

FDA source

Cardinal Health 200, LLC began a recall of ChemoPlus Chemo Spill Kit Product Code:DP5016K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills on 2019-03-22. FDA classified it as Class II and gives the reason as "Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1284-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-22
Posted: 2019-05-06
Terminated: 2021-08-06
Recalling firm: Medtronic, Inc.
Product: ChemoPlus Chemo Spill Kit Product Code:DP5016K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
Product code: LZA Polymer Patient Examination Glove
Reason for recall: Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Cardinal Health issued recall letter dated March 22, 2019 stating reason for recall, health risk and Action Required: 1. INSPECT inventory.2. SEGREGATE and QUARANTINE all on-hand product. 3. RETURN the enclosed acknowledgment form via fax to 847-689-9101 or 614-652-9648, whether or not you have affected product, indicating the product code, lot and quantity of product youve quarantined or discarded. 4. NOTIFY customers to whom you may have distributed, or forwarded product affected by this recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 5. CONTACT the appropriate Customer Service group to arrange for return and credit of any affected product Monday Friday between 8:00am - 5:00pm EST: Hospital800-964-5227 Federal Government800-444-1166 Distributor800-635-6021 All other customers888-444-5440. On 4/17/19 the firm issued the Correction Letter action and provided sticker labels-stating Warning Product contains natural rubber latex which may cause an allergic reaction. Action to take: INSPECT your inventory for the affected product code and lot number (listed on package) .SEGREGATE and QUARANTINE all on-hand product. 3. AFFIX the enclosed warning label on the principal display panel over the current not made with natural latex labeling (if applicable) on affected kits as shown in example 1. 4. ADDITIONAL labels can be obtained by contacting 800-292-9332 or [email protected] for assistance.
Quantity in commerce: 21082
Distribution: Worldwide Distribution - US Nationwide: Foreign: Bahamas, Canada, Chile, Guam, Israel, Japan
Product codes and lots: Lot Numbers: 708265X, 709766X, 712108X, 713853X, 719505X, 723645X, 726111X, 727029X, 730304X, 735321X, 803307X, 803990X, 808097X, 809318X, 812914X, 815537X, 821910X, 825016X, 826407X, 833752X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1284-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1283-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-06
Z-1284-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-06
Z-1285-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-06
Z-1286-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-06

Product code LZA

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)