Recall Z-0948-2018— Cook Inc.
Class II · Terminated
Class II FDA medical device recall by Cook Inc., initiated 2017-10-13, terminated 2019-10-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Amplatz Extra Stiff Wire Guide. Reason: Label does not state that the product is heparin-coated..
- Recalling firm
- Cook Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-10-13
- Terminated
- 2019-10-23
- Firm location
- Bloomington, IN, United States
Product description
Amplatz Extra Stiff Wire Guide
Reason for recall
Label does not state that the product is heparin-coated.
Data sourced from openFDA. This site is unofficial and independent of the FDA.