FDA (Devices) recall action 82677
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Remel Inc is recalling Thio Med w/Dex, Hem, Vit K media because it may fail performance testing after 57 days. The expiration date is shortened to 56 days.
Remel Inc is recalling Thio Med w/Dex, Hemin, Vit K media because the products may fail performance testing after 57 days.
Remel Inc is recalling 8,615 units of Thio Med w/Dex, Hem, Vit K media due to potential performance failures starting 57 days after manufacturing.
Remel Inc is recalling Thio Med w/Dex, Hem, Vit, K media because it may fail performance testing after 57 days. The expiration date is shortened to 56 days.