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Terminated

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 Recall Z-0532-2013 · Posted 2012-12-17

Recalling FirmMedline Industries Inc
Recall StatusTerminated
Product CodeLRO
Date Initiated2012-09-20
Date Terminated2012-12-17
Product Quantity18 packs

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.

Firm Action

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.

Root Cause

Packaging

Distribution Pattern

US (nationwide) in the state of West Virginia

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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