Non-sterile procedural knee trays recalled for potential packaging breach
Medline Industries recalls non-sterile Total Knee procedural trays because sterile blades inside can puncture the outer foil packaging. This could compromise sterile blade integrity.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with potential risk of sterile packaging breach, but no reported illnesses or injuries. Per the rubric, products with risk of harm where injury has not been reported warrant a High (3) severity score.
Plain-English summary
Medline Industries, LP is recalling non-sterile procedural trays labeled as TOTAL KNEE KIT, Item Number DYNJ904310F. The affected product consists of 16 units (Lot Number 22IBD724) distributed in Arkansas, Maryland, Washington, and Wisconsin.
The kits contain sterile surgical blades. There is potential for these sterile blades to puncture the outer foil layer of the kit, causing a breach in the sterile packaging of the blades.
A breach in the sterile packaging could compromise the sterile integrity of the blades prior to use.
The recalled product
- Product
- Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 16
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 (4)
- Item Number: DYNJ904310F
- UDI/GTIN Case: 40195327116188
- UDI/GTIN Each: 10195327116187
- Lot Number: 22IBD724
Distribution
Part of a larger recall action
This product is one of 7 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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