Neuro Convenience Kit recalled due to expired injectable component
Medline Industries is recalling the Neuro Convenience Kit because a NaCl injectable component expired in April 2020 while the kit's overall expiration date was later. The expired component may pose a safety risk.
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 3/5 (High).
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: This FDA Class II recall involves an expired injectable component within a medical device kit. Although the expired component poses a potential safety risk, no illnesses or injuries have been reported, placing this at the High severity level per the risk-of-harm rubric criterion.
Plain-English summary
Medline Industries Inc is recalling the Neuro Convenience Kit (Model #DYNJ905194, Lot #19HBK497) due to a component expiration discrepancy. The kit contains a NaCl 250 mL injectable solution that expired in April 2020, while the overall kit's expiration date was after April 2020.
An expired injectable solution may not maintain proper sterility or potency, creating a potential safety risk if administered to patients.
The affected kits were distributed nationwide in the United States. Healthcare facilities and practitioners who have kits from this lot should discontinue use and contact Medline Industries Inc for replacement or return instructions.
The recalled product
- Product
- Neuro Convenience Kit
- Manufacturer
- Medline Industries Inc
- Hazard
- Affected units
- 30
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Medline Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →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
- HighEVLP Convenience Pack Recalled for Expired Injectable Component
FDA (Devices) · 2021-12-22
- HighMedline Venous Access Pack-LF Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighMedline Vascular CDS Kit Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
Similar recalls
- ModerateMedline Total Knee Surgical Kit Recalled for Expired Irrigation Component
FDA (Devices) · 2021-08-18
- HighMedline Shoulder CDS Kits Recalled Due to Expired Irrigation Component
FDA (Devices) · 2021-08-18
- HighMedline Knee Arthroscopy Kit Recalled for Expired Irrigation Component
FDA (Devices) · 2021-08-18
- HighMedline Arthroscopy Kit Recalled for Expired Irrigation Component
FDA (Devices) · 2021-08-18
- HighMedline C-Section Convenience Kits Recalled for Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Neuro IR Surgical Kit Recalled Due to Weak Seals
FDA (Devices) · 2024-07-10