Recall Z-0365-2017— Covidien LLC
Class II · Terminated
Class II FDA medical device recall by Covidien LLC, initiated 2016-09-29, terminated 2019-04-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles. Reason: Added Instructions for Use: After application, inspect the Light Glove for barrier integrity.
- Recalling firm
- Covidien LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-29
- Terminated
- 2019-04-05
- Firm location
- North Haven, CT, United States
Product description
Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
Reason for recall
Added Instructions for Use: After application, inspect the Light Glove for barrier integrity
Data sourced from openFDA. This site is unofficial and independent of the FDA.