FDA (Devices) recall action 99297
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
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 certain MEDLINE medical procedure convenience kits because they contain ICU Medical, Inc. pain management kits that may be ineffective.
Medline Industries is recalling 318 medical procedure kits that contain ICU Medical pain management kits with Bupivacaine Hydrochloride in Dextrose Injection due to quality issues that could result in drug ineffectiveness.