FDA Recall
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.
Recall: Z-0532-2013
·
Initiated September 20, 2012
Recall
- Recall Number
- Z-0532-2013
- Event Number
- 63520
- Firm
- Medline Industries Inc
- FEI Number
- 1417592
- Product Code
- LRO
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- September 20, 2012
- Posted
- December 17, 2012
- Terminated
- December 17, 2012
- Address
- 1 Medline Pl, Mundelein, IL, 60060
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
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.
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.
Distribution
US (nationwide) in the state of West Virginia
Quantity
18 packs