CIVCO Sales Demo Kit recall: Sterility Concern
CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic…
Why was CIVCO Sales Demo Kit recalled?
Sterility of the product cannot be assured.
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?
M116270, M119900, M121920, M125640, M130290, M170900, M185950, M204790, M211280, M215550, M235410, M240880, M252870, M303130, M320620, M320660, M346050, M368820, M379870, M391260, M395270, M418200, M476020, M497220, M508200, M594740, M598320, and M624430
- Product
- CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic…
- Recalling firm
- Civco Medical Instruments Co. Inc.
- Quantity
- 54 boxes
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHILE, CHINA (MAINLAND), CHINA (TAIWAN), CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KUWAIT, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PUERTO RICO, QATAR, SOUTH AFRICA, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, SWITZERLAND, TRINIDAD AND TOBAGO, TURKEY, UGANDA, UKRAINE, and UNITED KINGDOM.
- Recall date
- November 25, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)