Medline Spinal Block Syringes Recalled for Quality Defects
Medline is recalling spinal block syringes due to leaks, breakage, and other quality issues identified in an FDA safety alert. The recalled lots have worldwide distribution and span from 2019 to 2023.
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 Class II FDA recall involves medical devices with identified quality defects (leaks and breakage) that pose a risk to patient health. Although no illnesses or injuries have been reported, the nature of the defect in devices used for spinal procedures creates a risk-of-harm situation, meeting the High severity threshold.
Plain-English summary
Medline Industries is recalling convenience kits containing plastic spinal block syringes (Pack Number DYNJRA9026). The recall follows an FDA Safety Alert issued on March 19, 2024. The syringes have been identified with leaks, breakage, and other quality issues that may pose a risk to patient health.
The affected syringes have worldwide distribution. Multiple lot numbers are affected spanning 2019 through 2023, including 22EBN191, 22LBC356, 23ABN403, 23CBP475, 23DBG934, 23EBH050, 23JBS641, 23KBJ179, 23LBU686, 19ADC324, 19ADD208, 19LDA087, 19LDB132, 20ADC808, 20BDA346, 20BDB555, 20CDB731, 20EDC526, 20GDA908, 20IDA046, 20IDA621, 20LDB113, 20LDB323, 21BDA498, 21DDA458, 21DDA663, 21HDC456, 21JDB091, 21KDC632, 21LDA581, 21LDB014, 22BDA209, 22BDC191, 22CDA655, 22CDC010, 22ILB005, and 22KLA115.
The recalled product
- Product
- Medline Convenience kits, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Pack Number DYNJRA9026
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Syringes
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 (20)
- DYNJRA9026
- Lot Number 22EBN191
- Lot Number 22LBC356
- Lot Number 23ABN403
- Lot Number 23CBP475
- Lot Number 23DBG934
- Lot Number 23EBH050
- Lot Number 23JBS641
- Lot Number 23KBJ179
- Lot Number 23LBU686
- Lot Number 19ADC324
- Lot Number 19ADD208
- Lot Number 19LDA087
- Lot Number 19LDB132
- Lot Number 20ADC808
- Lot Number 20BDA346
- Lot Number 20BDB555
- Lot Number 20CDB731
- Lot Number 20EDC526
- Lot Number 20GDA908
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 81 recalled by MEDLINE INDUSTRIES, LP - Northfield 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.
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