Centurion EP LAB Instrument KIT recall: Sterility Concern
Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit
Why was Centurion EP LAB Instrument KIT recalled?
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 40653160307816 (each), 10653160307815 (case), Lot Numbers: 23LBK889
- Product
- Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 90 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Panama.
- Recall date
- October 30, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)