Recall Z-2804-2017— International Medsurg Connection, Inc.
Class II · Terminated
Class II FDA medical device recall by International Medsurg Connection, Inc., initiated 2017-06-23, terminated 2020-08-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Syringe Bulb, 60 CC 50 pcs per case. The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.. Reason: Insufficient documentation to support product sterility claims..
- Recalling firm
- International Medsurg Connection, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-23
- Terminated
- 2020-08-24
- Firm location
- Schaumburg, IL, United States
Product description
Syringe Bulb, 60 CC 50 pcs per case. The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Reason for recall
Insufficient documentation to support product sterility claims.
Data sourced from openFDA. This site is unofficial and independent of the FDA.