Recall Z-1992-2015— Stradis Healthcare, LLC.
Class II · Completed
Class II FDA medical device recall by Stradis Healthcare, LLC., initiated 2015-04-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Breast Pack - contains Devon Light Glove Used during surgery. Reason: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits..
- Recalling firm
- Stradis Healthcare, LLC.
- Classification
- Class II
- Status
- Completed
- Initiated
- 2015-04-20
- Firm location
- Lawrenceville, GA, United States
Product description
Breast Pack - contains Devon Light Glove Used during surgery
Reason for recall
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Data sourced from openFDA. This site is unofficial and independent of the FDA.