Date Initiated by Firm | September 20, 2012 |
Date Posted | December 17, 2012 |
Recall Status1 |
Terminated 3 on December 17, 2012 |
Recall Number | Z-0532-2013 |
Recall Event ID |
63520 |
Product Classification |
General surgery tray (kit) - Product Code LRO
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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. |
Code Information |
Reorder #CDS983828, lot numbers 12HD0901 and 12IB1848, expiration date 09/30/2013 |
Recalling Firm/ Manufacturer |
Medline Industries Inc 1 Medline Pl Mundelein IL 60060
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For Additional Information Contact | 847-949-3051 |
Manufacturer 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. |
FDA Determined Cause 2 | Packaging |
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. |
Quantity in Commerce | 18 packs |
Distribution | US (nationwide) in the state of West Virginia |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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