Glidesheath Slender Hydrophilic Coated Introducer recall: Sterility Concern
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.025), REF/Product Code RM*ES6J10HAT, STERILE, Rx ONLY
Why was Glidesheath Slender Hydrophilic Coated Introducer recalled?
An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
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?
Lot s 161018, 161116, 161117, 161213, 161214, 170118, 170119
- Product
- Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.025), REF/Product Code RM*ES6J10HAT, STERILE, Rx ONLY
- Recalling firm
- Terumo Medical Corp
- Quantity
- N/A
- Distribution
- Nationwide and Canada
- Recall date
- December 20, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)