||December 17, 2012
||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.
||Reorder #CDS983828, lot numbers 12HD0901 and 12IB1848, expiration date 09/30/2013
|Medline Industries Inc
1 Medline Pl
Mundelein, Illinois 60060
|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.
||Medline Industries Inc notified the sole direct account on September 20, 2012 via telephone that the affected custom pack were recalled. Instruction was provided to the staff at the facility not to use the pack until it had been reworked with a sterile back table cover.
|Quantity in Commerce
||US (nationwide) in the state of West Virginia