Recall Z-2119-2015— 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: Hysto Pack, Non-sterile Part Number Description SA2059B MAJOR BASIN SA2220 HYSTO PACK SA2220A HYSTO PACK. 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
Hysto Pack, Non-sterile Part Number Description SA2059B MAJOR BASIN SA2220 HYSTO PACK SA2220A HYSTO PACK
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.