Medline Recalls RNA Medical Hemoglobin Control Product Due to Shipment Compromise
Medline Industries is recalling 4 units of RNA Medical Hemoglobin Control product because the product was compromised during shipment. The recall affects distribution in Kentucky, Pennsylvania, and Ohio.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text states the product was compromised during shipment but does not report any illnesses, injuries, or specific contamination hazards, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Medline Industries Inc is recalling 4 units of RNA Medical, QCHGB Hemoglobin Control, Multi, Ref QC HGB. This product is used to monitor the performance of Hemocue Hemoglobin Analyzers by providing a method for periodic quality control checks to verify correct system measurement.
The recall was initiated because the product was compromised during shipment. The affected lot number is 072564. The product was distributed nationwide in the states of Kentucky, Pennsylvania, and Ohio.
Consumers and healthcare facilities should stop using the affected product and contact Medline Industries Inc for further instructions or a replacement.
The recalled product
- Product
- RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It provides a convenient method of performing periodic QC checks to verify correct system measurement.
- Manufacturer
- Medline Industries Inc
- Hazard
- Affected units
- 4
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 072564
Distribution
Related recalls
Same manufacturer · Medline Industries Inc
See all →- HighMedline Chest Tube Kit Recalled for Non-Sterile Tape Component
FDA (Devices) · 2022-09-14
- ModerateMedline Hand Sanitizer Foam Recalled for Defective Containers
FDA (Drugs) · 2021-12-29
- ModerateBedside PICC CDS Convenience Kit Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighMedline Venous Access Pack-LF Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighEVLP Convenience Pack Recalled for Expired Injectable Component
FDA (Devices) · 2021-12-22
Similar recalls
- LowMedline Recalls STAT-Site B-HB Controls Due to Shipment Compromise
FDA (Devices) · 2021-03-03
- ModerateMedical Device Linearity Standards Recalled Due to Improper Storage Controls
FDA (Devices) · 2022-04-20
- HighSiemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Interference
FDA (Devices) · 2018-09-05
- HighSiemens RAPIDLab Blood Gas Analyzer Recalled for Hydroxocobalamin Interference
FDA (Devices) · 2018-09-05
- HighEurotrol HemoTrol Level 3 Recalled Due to Microbial Contamination
FDA (Devices) · 2018-12-05
- SevereEurotrol HemoTrol Level 2 Recalled Due to Microbial Contamination
FDA (Devices) · 2018-12-05