CLASS II Device recall · Reported 15 May 2019 · FDA Enforcement Report
ChemoPlus Chemo Spill Kit Product recalled by Cardinal Health 200
Cardinal Health 200 is recalling ChemoPlus Chemo Spill Kit, distributed nationwide in the US. The recall was initiated on 22 Mar 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1284-2019
- FDA event ID
- 82535
- Recalling firm
- Cardinal Health 200, Mansfield, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Mar 2019
- FDA classified
- 6 May 2019
- Reported
- 15 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 22 Mar 2019 | Recall initiated by company | |
| 6 May 2019 | Classified by FDA | +45 days |
| 15 May 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
ChemoPlus Chemo Spill Kit Product Code:DP5016K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
Where it was distributed
Worldwide Distribution - US Nationwide: Foreign: Bahamas, Canada, Chile, Guam, Israel, Japan
Questions about this recall
Why was it recalled?
Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
Which lots are affected?
Lot Numbers: 708265X, 709766X, 712108X, 713853X, 719505X, 723645X, 726111X, 727029X, 730304X, 735321X, 803307X, 803990X, 808097X, 809318X, 812914X, 815537X, 821910X, 825016X, 826407X, 833752X
Where was it sold?
Worldwide Distribution - US Nationwide: Foreign: Bahamas, Canada, Chile, Guam, Israel, Japan
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 82535This product is part of a recall event; the main page for the event is ChemoPlus Chemo Spill Kit Product recalled by Cardinal Health 200.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ChemoPlus Chemo Spill Kit Product recalled by Cardinal Health 200 | Cardinal Health 200 | Foreign Material | Nationwide | |
| CLASS II | ChemoPlus Chemo Spill Kit, Home Health Kit Product recalled | Cardinal Health 200 | Foreign Material | Nationwide | |
| CLASS II | ChemoPlus Protective Wrap-around Goggles Product recalled | Cardinal Health 200 | Foreign Material | Nationwide |
More recalls from Cardinal Health 200
All 283| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |