Recall Z-0366-2017— 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: Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Number Description 380789003 SURE SET SINGLE BASIN PACK 400383006 MAJOR BASIN PACK 400383007 MAJOR BASIN PACK 618275004 BASIN PACK 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
Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Number Description 380789003 SURE SET SINGLE BASIN PACK 400383006 MAJOR BASIN PACK 400383007 MAJOR BASIN PACK 618275004 BASIN PACK 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.