LeverEdge Contrast Injector: 35 cc syringe with ISO 594 recall: Particulate Matter
LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the…
Why was LeverEdge Contrast Injector: 35 cc syringe with ISO 594 recalled?
The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: LCI1091, LCI1092, LCI1093, LCI1094, LCI1095, LCI1096, LCI1097, LCI1098, LCI1099
- Product
- LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the…
- Recalling firm
- LeMaitre Vascular, Inc.
- Quantity
- 616 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, CA, FL, IL, IN, KY, MA, MO, NY, OH, TN, TX and the countries of Bahamas, Belgium, France, Germany, Hong Kong, Spain.
- Recall date
- May 12, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)