Medline Nerve Block Kits Recalled for Defective Plastic Syringes
Medline is recalling nerve block convenience kits for defective plastic syringes that may leak or break, creating a patient safety risk during medical procedures.
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: This is a Class II FDA recall of a risk-of-harm medical device used in clinical nerve block procedures. The defective plastic syringes may leak or break, creating a direct patient safety hazard. Although no injuries have been reported, the defects in a critical medical device component warrant a High severity rating per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling two types of medical convenience kits: the Nerve Block Tray-LF (Pack Number DYNJRA0377B) and the Peripheral Nerve Block kit (Pack Number PAIN0137). These kits contain plastic syringes and are used to administer nerve block anesthesia in medical settings.
The plastic syringes in these kits are affected by an FDA Safety Alert issued on March 19, 2024. The syringes have quality defects including leaks, breakage, and other issues that may pose a risk to patient health during medical procedures.
The affected kits were distributed worldwide. The following lot numbers are recalled: For the Nerve Block Tray-LF (DYNJRA0377B), Lot Numbers 19DDB791 and 21KDA359. For the Peripheral Nerve Block kit (PAIN0137), the affected lot numbers are 21CLA312, 21ALA608, 20LLA425, 20JLA143, 20HLA191, 20GLA104, 20CLA627, 20BLA634, and 20ALA243.
The recalled product
- Product
- Medline Convenience kits, labeled as: 1) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0377B; 2) PERIPHERAL NERVE BLOCK, Pack Number PAIN0137
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Nerve Block Kit
- Hazard
- syringe-leakage
- syringe-breakage
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 (13)
- DYNJRA0377B
- Lot Number 19DDB791
- Lot Number 21KDA359
- PAIN0137
- Lot Number 21CLA312
- Lot Number 21ALA608
- Lot Number 20LLA425
- Lot Number 20JLA143
- Lot Number 20HLA191
- Lot Number 20GLA104
- Lot Number 20CLA627
- Lot Number 20BLA634
- Lot Number 20ALA243
Distribution
Distribution scope not specified by the agency.
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