Covidien Clearify Visualization System recall: Sterility Concern
Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent…
Why was Covidien Clearify Visualization System recalled?
Product sterility is compromised due to breach of the sterile barrier
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?
Lots beginning with: P4J, P4K, P4L, P4M, P5A, P5B, P5C, P5D, P5E, P5F, P5G, P5H, P5J, P5K, P5L, P5M, P6A, P6B, P6C, P6D and lots P6E0016GX,P6E0049GX, , P6E0050GX, P6E0051GX, P6E0052GX, P6E0163GX, P6E0164GX, P6E0212GX
- Product
- Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent…
- Recalling firm
- Medtronic
- Quantity
- 1,293,169 systems
- Distribution
- Worldwide Distribution - US (Nationwide) Foreign: Austria Belgium Bulgaria Brazil Chile Cyprus Denmark Egypt Finland France France Germany Greece Hungary Iran Ireland Israel Italy Japan Kenya Kuwait Latvia Luxembourg Mexico Namibia Netherlands Nigeria Norway Poland Portugal Romania Saudi Arabia Serbia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom
- Recall date
- December 28, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)