Recall Z-0532-2013— Medline Industries Inc
Class II · Terminated
Class II FDA medical device recall by Medline Industries Inc, initiated 2012-09-20, terminated 2012-12-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table cover; Product Usage: This Complete Delivery Systems (CDS) custom pack includes components necessary for a total knee replacement surgical procedure.. Reason: The Back Table Cover component in the custom pack was placed in the non-sterile portion of the pack when it should have been in the sterile portion..
- Recalling firm
- Medline Industries Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-20
- Terminated
- 2012-12-17
- Firm location
- Mundelein, IL, United States
Product description
Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table cover; Product Usage: This Complete Delivery Systems (CDS) custom pack includes components necessary for a total knee replacement surgical procedure.
Reason for recall
The Back Table Cover component in the custom pack was placed in the non-sterile portion of the pack when it should have been in the sterile portion.
Data sourced from openFDA. This site is unofficial and independent of the FDA.