Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table cover; Prod
FDA device recall Z-0532-2013 · posted 2012-12-17 · Terminated
Recall details
- Recalling firm
- Medline Industries Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LRO
- Quantity affected
- 18 packs
- Distribution
- US (nationwide) in the state of West Virginia
- Date initiated
- 2012-09-20
- Date posted
- 2012-12-17
- Date terminated
- 2012-12-17
- Location
- Mundelein, IL
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