Centurion Difficult IV Kit Recalled for False Carboxyhemoglobin Results
Centurion Medical Products is recalling 140 Difficult IV Kits containing BD Vacutainer tubes that may cause false carboxyhemoglobin results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that produces inaccurate diagnostic results (false elevation of carboxyhemoglobin), which poses a risk of harm through misdiagnosis, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Centurion Medical Products Corporation is recalling 140 units of the Centurion DIFFICULT IV KIT (Kit Code: IV8860). The kits contain BD Vacutainer Plastic Lithium Heparin Tubes (BD Codes 367884 & 367960; Centurion codes 45177 and 84815). The specific lot number is 2019050790, with an expiration date of 10/31/2019.
The recall was initiated because blood samples collected using these specific tubes may produce false elevation of carboxyhemoglobin (COHb) results when analyzed with the IL GEM 4000 instrument. This issue could lead to inaccurate diagnostic data for patients.
The affected products were distributed nationwide in the United States, including in the state of Illinois. Healthcare facilities and laboratories should stop using the affected kits and contact Centurion Medical Products Corporation for instructions on returning or disposing of the product.
The recalled product
- Product
- 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
- Manufacturer
- Centurion Medical Products Corporation
- Affected units
- 140
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 2019050790 exp. Date: 10/31/2019
Distribution
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