FDA Enforcement
Class II
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
·
Reported December 26, 2012
Enforcement
- Recall Number
- Z-0532-2013
- Event ID
- 63520
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medline Industries Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- December 26, 2012
- Initiation Date
- September 20, 2012
- Classification Date
- December 17, 2012
- Termination Date
- December 17, 2012
- Address
- 1 Medline Pl, Mundelein, IL, 60060, United States
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.
Code Info
Reorder #CDS983828, lot numbers 12HD0901 and 12IB1848, expiration date 09/30/2013
Distribution
US (nationwide) in the state of West Virginia
Quantity
18 packs