Recall Z-1790-2017— Windstone Medical Packaging, Inc.
Class II · Terminated
Class II FDA medical device recall by Windstone Medical Packaging, Inc., initiated 2017-03-16, terminated 2017-06-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 Product packaged in a convenient manner for use in a general clinical procedure. Reason: AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised..
- Recalling firm
- Windstone Medical Packaging, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-03-16
- Terminated
- 2017-06-06
- Firm location
- Billings, MT, United States
Product description
Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 Product packaged in a convenient manner for use in a general clinical procedure
Reason for recall
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
Data sourced from openFDA. This site is unofficial and independent of the FDA.