Centurion Manual surgical kits labeled as: a) recall: Sterility Concern
Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code 15MLVLCP; b) STERILE 9X12 RECLOSABLE BAG, Product Code MG912ST
Why was Centurion Manual surgical kits labeled as: a) recalled?
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
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?
a) 15MLVLCP, UDI/DI 50653160021306 (case) 00653160021301 (each), Lot Numbers: 2023102790 b) MG912ST, UDI/DI 10653160122906 (case) 00653160122909 (each), Lot Numbers: 2023022190
- Product
- Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code 15MLVLCP; b) STERILE 9X12 RECLOSABLE BAG, Product Code MG912ST
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 1700 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama, Canada.
- Recall date
- April 10, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)