—#114135

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.

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Reorder #CDS983828, lot numbers 12HD0901 and 12IB1848, expiration date 09/30/2013

Why it was recalled

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.

Root cause (FDA determination)

Packaging

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: 1 Medline Pl, Mundelein, Illinois 60060

Distribution

Distribution pattern: US (nationwide) in the state of West Virginia

Timeline

Recall initiated: 2012-09-20
Posted by FDA: 2012-12-17
Terminated: 2012-12-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114135. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.