K-204 Guide Sheath KIT 2.6mm recall: Sterility Concern
K-204 GUIDE SHEATH KIT 2.6MM, model no. K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Why was K-204 Guide Sheath KIT 2.6mm recalled?
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK
- Product
- K-204 GUIDE SHEATH KIT 2.6MM, model no. K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
- Recalling firm
- Aomori Olympus Co., Ltd.
- Quantity
- 7,400,000 (globally); 260,395 (US)
- Distribution
- US Nationwide distribution.
- Recall date
- February 17, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)