CLASS II Device recall · Reported 15 Jul 2020 · FDA Enforcement Report
Centurion Difficult IV KIT containing BD's Vacutainer recalled
Centurion Medical Products is recalling Centurion Difficult IV KIT containing BD's Vacutainer Plastic Lithium Heparin Tubes (BD, distributed nationwide in the US. The recall was initiated on 1 Jun 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-2545-2020
- FDA event ID
- 85494
- Recalling firm
- Centurion Medical Products, Williamston, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Jun 2019
- FDA classified
- 9 Jul 2020
- Reported
- 15 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 1 Jun 2019 | Recall initiated by company | |
| 9 Jul 2020 | Classified by FDA | +404 days |
| 15 Jul 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
False elevation of carboxyhemoglobin (COHb) results in blood samples collected using BD Vacutainer¿ Plastic Lithium Heparin tubes with the IL GEM 4000 instrument.
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
Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Heparin Tubes (BD Vacutainer-BD Codes 367884 & 367960; Centurion code 45177 (VACUTAINER GREEN TOP) and 84815 (VACUTAINER 3ML LT. GREEN). Centurion Kit Code: IV8860
Where it was distributed
US Nationwide distribution including in the state of IL.
Questions about this recall
Why was it recalled?
False elevation of carboxyhemoglobin (COHb) results in blood samples collected using BD Vacutainer¿ Plastic Lithium Heparin tubes with the IL GEM 4000 instrument.
Which lots are affected?
Lot Number: 2019050790 exp. Date: 10/31/2019
Where was it sold?
US Nationwide distribution including in the state of IL.
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.
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