Medline Total Knee CDS Recalled for Sterile Component Misplacement
Medline Industries is recalling 18 Total Knee CDS packs because a back table cover was placed in the non-sterile portion of the pack instead of the sterile portion.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The issue is a packaging/sterility error without reported injuries, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Medline Industries Inc is recalling 18 packs of the Medline Total Knee CDS, a single patient prescription procedure pack and disposables used for total knee replacement surgical procedures. The recall involves Reorder #CDS983828, lot numbers 12HD0901 and 12IB1848, with an expiration date of 09/30/2013.
The recall was initiated because 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. This packaging error affects the sterility integrity of the surgical kit.
The affected products were distributed nationwide in the state of West Virginia. Healthcare facilities and providers who have received these specific packs should stop using them and contact Medline Industries for further instructions.
The recalled product
- 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.
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Surgical Packs
- Affected units
- 18
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Reorder #CDS983828
- lot numbers 12HD0901 and 12IB1848
- expiration date 09/30/2013
Distribution
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