Medtronic Recalls Sterile Mouse Bags Due to Sterility Control Issues
Medtronic Navigation is recalling sterile mouse bags because returned devices may not have been properly examined for damage that could compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a sterile medical device where sterility assurance is compromised due to lack of control over returned items. This represents a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Medtronic Navigation, Inc. is recalling certain single-use, disposable sterile mouse bags (Product Code: BAG 9732315 MOUSE STERILE 15 PK). The recall affects 26,674 units distributed nationwide. The specific lot numbers involved are 5246110712 and 5316560113.
The recall was initiated because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage. This lack of control raises concerns that the sterility of the devices may not be assured.
Healthcare facilities and consumers should stop using these specific sterile mouse bags immediately. Users should check their inventory for the product code and lot numbers listed above. If the product is found, it should be quarantined and returned to Medtronic Navigation or the distributor in accordance with the recall instructions.
The recalled product
- Product
- BAG 9732315 MOUSE STERILE 15 PK
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 26,674
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 (1)
- Lot No.: 5246110712 5316560113
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 25 recalled by Medtronic Navigation, Inc. 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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