Recall Z-2107-2015— Covidien LLC
Class II · Terminated
Class II FDA medical device recall by Covidien LLC, initiated 2015-04-16, terminated 2017-06-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Delivery/C-Section, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 56479 7335-SMC C-Section Kit 31404851 7382-OTO2 Delivery Kit 52000076E 7339-ES C-SECTION DELUXE PACK 52000082E 7335-HUV DELIVERY KIT. Reason: Devon Light Gloves contain splits or holes compromising the sterility.
- Recalling firm
- Covidien LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-16
- Terminated
- 2017-06-28
- Firm location
- North Haven, CT, United States
Product description
Delivery/C-Section, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 56479 7335-SMC C-Section Kit 31404851 7382-OTO2 Delivery Kit 52000076E 7339-ES C-SECTION DELUXE PACK 52000082E 7335-HUV DELIVERY KIT
Reason for recall
Devon Light Gloves contain splits or holes compromising the sterility
Data sourced from openFDA. This site is unofficial and independent of the FDA.