Best Practices kits containing certain production recall: Sterility Concern
Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during…
Why was Best Practices kits containing certain production 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?
Kit Parent Codes: 00Z2224 00Z2232 00Z2298 00Z2363 00Z2364 00Z2365 00Z2366 00Z2421 00Z2425 00Z2430 00Z2431 00Z2460 00Z2493 00Z2534 00Z2535 000Z2544 00Z5000B 00Z5001B GYNKIT2
- Product
- Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during…
- Recalling firm
- Medtronic
- Quantity
- 230 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)