FDAFDA · Food and drugs·Recall number Z-0532-2013
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.
Published December 26, 2012 · Recall initiated: September 20, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Medline Industries Inc
- Distributor
- US (nationwide) in the state of West Virginia
- Lot
- Reorder #CDS983828, lot numbers 12HD0901 and 12IB1848, expiration date 09/30/2013
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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