Medline Cardiac Pacing Kits Recalled for Syringe Quality Issues
Medline is recalling cardiac pacing kits containing plastic syringes with leaks or breakage risks. The recall addresses quality issues that may pose a risk to patient health.
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 is classified as FDA Class II and involves a risk to patient health due to syringe defects, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Medline Industries, LP is recalling specific convenience kits labeled as CARDIAC PACING PACK, Pack Number DYNJ41223. These kits contain plastic syringes that are affected by an FDA Safety Alert issued on March 19, 2024. The recall covers multiple lot numbers, including 21HBU861, 21KBA848, and 21KBA910, among others.
The recall is being conducted because leaks, breakage, and other quality issues have been identified in the plastic syringes. These defects may pose a risk to patient health. The agency has classified this recall as Class II.
The affected products were distributed worldwide. Consumers and healthcare providers should stop using the affected kits and contact Medline Industries for further instructions or a replacement.
The recalled product
- Product
- Medline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ41223
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
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)
- DYNJ41223
- Lot Number 21HBU861
- Lot Number 21KBA848
- Lot Number 21KBA910
- Lot Number 22ABA546
- Lot Number 22MBA262
- Lot Number 19BBC903
- Lot Number 19CBO901
- Lot Number 19DBW422
- Lot Number 22HBY065
- Lot Number 19HBD957
- Lot Number 19HBJ856
- Lot Number 19IBT476
- Lot Number 22KBU048
- Lot Number 19VBD385
- Lot Number 19LBF954
- Lot Number 23EBC280
- Lot Number 23FBA251
- Lot Number 20BBP883
- Lot Number 20CBI263
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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