FDA (Devices) recall action 99290
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.
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.
Medline Industries, LP is recalling specific Medline kits containing B. Braun convenience kits because they include Bupivacaine Hydrochloride in Dextrose Injection, USP, which has been recalled due to quality issues.
Medline Industries, LP is recalling specific C-Section convenience kits because they contain Bupivacaine Hydrochloride in Dextrose Injection, USP, which is subject to a voluntary recall due to quality issues.
Medline Industries, LP is recalling 2301 convenience kits used in orthopedic joint procedures because they contain B. Braun kits with Bupivacaine Hydrochloride in Dextrose Injection, USP, which the manufacturer Huons Co, Ltd. voluntarily recalled due to quality issues.