CLASS II Device recall · Reported 29 Jan 2020 · FDA Enforcement Report
Henry Schein CardioChek Starter Kit recalled
Polymer Technology Systems is recalling Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036, distributed nationwide in the US. The recall was initiated on 2 Dec 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-0834-2020
- FDA event ID
- 84274
- Recalling firm
- Polymer Technology Systems, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Dec 2019
- FDA classified
- 21 Jan 2020
- Reported
- 29 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 2 Dec 2019 | Recall initiated by company | |
| 21 Jan 2020 | Classified by FDA | +50 days |
| 29 Jan 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036
Where it was distributed
The products were distributed US Nationwide. The products were distributed to the following foreign countries: Australia, Austria, Belgium, Bermuda, Canada, China, Chile, Costa Rica, Cayman Islands, Czech Republic, England, Finland, France, Germany, Greece, Hong Kong, India, Iraq, Italy, Jordan, Lebanon, Lithuania, Mexico, Morocco, Panama, Philippines, Poland, Qatar, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Trinidad, UAE.
Questions about this recall
Why was it recalled?
One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.
Which lots are affected?
All Serial Numbers shipped during the 11/1/2016 to 10/25/2019 timeframe. UDI: 00304040040539
Where was it sold?
The products were distributed US Nationwide. The products were distributed to the following foreign countries: Australia, Austria, Belgium, Bermuda, Canada, China, Chile, Costa Rica, Cayman Islands, Czech Republic, England, Finland, France, Germany, Greece, Hong Kong, India, Iraq, Italy, Jordan, Lebanon, Lithuania, Mexico, Morocco, Panama, Philippines, Poland, Qatar, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Trinidad, UAE.
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 84274This product is part of a recall event; the main page for the event is PTS Diagnostics CardioChek Plus Professional Analyzer recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | PTS Diagnostics CardioChek Plus Professional Analyzer recalled | Polymer Technology Systems | Device Malfunction | Nationwide | |
| CLASS II | PTS Diagnostics CardioChek Plus Professional Analyzer recalled | Polymer Technology Systems | Device Malfunction | Nationwide | |
| CLASS II | Henry Schein CardioChek Plus Professional Analyzer recalled | Polymer Technology Systems | Device Malfunction | Nationwide |
More recalls from Polymer Technology Systems
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | A1CNow+ Multi-Test HbA1c System consists recalled | Polymer Technology Systems | Labeling Errors | Nationwide |
| Device | CLASS III | PTS Panels CHOL+GLU Test Strips recalled by Polymer Technology Systems | Polymer Technology Systems | Packaging Defects | Nationwide |
| Device | CLASS II | PTS Detect Cotinine recalled by Polymer Technology Systems | Polymer Technology Systems | Other | Nationwide |
| Device | CLASS II | Henry Schein CardioChek Plus Professional Analyzer recalled | Polymer Technology Systems | Device Malfunction | Nationwide |
| Device | CLASS II | PTS Diagnostics CardioChek Plus Professional Analyzer recalled | Polymer Technology Systems | Device Malfunction | Nationwide |
Other Other Medical Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Major Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Mfc Craniotomy Pack recalled | Medline Industries | Other | Nationwide |