CLASS II Device recall · Reported 17 Feb 2021 · FDA Enforcement Report
Kendall Spill Kit, NonsterileI, BB6016K recalled by Cardinal Health 200
Cardinal Health 200 is recalling Kendall Spill Kit, NonsterileI, BB6016K, distributed nationwide in the US. The recall was initiated on 7 Jan 2021 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-1082-2021
- FDA event ID
- 87145
- Recalling firm
- Cardinal Health 200, Waukegan, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jan 2021
- FDA classified
- 5 Feb 2021
- Reported
- 17 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 7 Jan 2021 | Recall initiated by company | |
| 5 Feb 2021 | Classified by FDA | +29 days |
| 17 Feb 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
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
Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K
Where it was distributed
Global Distribution. US Nationwide.
Questions about this recall
Why was it recalled?
Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
Which lots are affected?
Lots: 916197X 916881X 919683X 920354X 924620X 928728X 931205X
Where was it sold?
Global Distribution. US Nationwide.
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
5 other products · FDA event 87145| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ChemoPlus Drug Spill Kit-Insti recalled by Cardinal Health 200 | Cardinal Health 200 | Foreign Material | Nationwide | |
| CLASS II | Covidien ChemoPlus Chemo Spill Kit, Nonsterile recalled | Cardinal Health 200 | Foreign Material | Nationwide | |
| CLASS II | ChemoPlus" Chemo Prep & Admin Kit, CT4025 recalled | Cardinal Health 200 | Foreign Material | Nationwide | |
| CLASS II | Chemobloc Preparation and Administration Kit recalled | Cardinal Health 200 | Foreign Material | Nationwide | |
| CLASS II | Chemoplus Drug Spill Kit Hos recalled by Cardinal Health 200 | 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 |