FDA (Devices) recall action 91069
The FDA (Devices) publishes a recall like this one as 40 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 40 pages.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
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.
ROi CPS LLC is recalling Regard LAMINECTOMY surgical convenience kits because they contain 3M surgical drapes that were subsequently recalled.
ROi CPS LLC recalled 76 regard Vitrectomy Pack surgical kits distributed in Louisiana, Missouri, North Carolina, and Florida because they contained 3M surgical drapes that were subsequently recalled.
ROi CPS LLC is recalling 188 regard SPINE PACK surgical convenience kits that contain 3M surgical drapes subject to a separate FDA recall. The affected lots should be removed from use.
ROi CPS LLC recalls 213 surgical convenience kits containing 3M surgical drapes that were subsequently recalled. The affected kits were distributed in Louisiana, Missouri, North Carolina, and Florida.
ROi CPS LLC is recalling regard BASIC NEURO surgical convenience kits containing 3M surgical drapes that were previously recalled. Affected units were distributed to LA, MO, NC, and FL.
ROi CPS LLC is recalling Regard hip arthroscopy surgical convenience kits containing 3M surgical drapes that were subsequently recalled. The kits were distributed in LA, MO, NC, and FL.
ROi CPS LLC is recalling 243 surgical convenience kits that contain recalled 3M surgical drapes. The kits were distributed in four states.
ROi CPS LLC is recalling 20 surgical convenience kits distributed in LA, MO, NC, and FL because they contain 3M surgical drapes that were subsequently recalled.
ROi CPS LLC is recalling Regard SHOULDER surgical convenience kits because they contain 3M surgical drapes that were subsequently recalled. Affected kits were distributed to healthcare facilities in LA, MO, NC, and FL.
ROi CPS LLC is recalling 90 regard shoulder arthroscopy surgical convenience kits because they contain 3M surgical drapes that were subsequently recalled. The kits were distributed in Louisiana, Missouri, North Carolina, and Florida.
ROi CPS LLC is recalling 738 regard CATARACT eye surgery convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida because they contain 3M surgical drapes that have been recalled.
Regard MAJOR EAR surgical convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida are being recalled because the kits contained 3M surgical drapes that were subsequently recalled.
ROi CPS LLC is recalling 248 regard NEURO TRAY neurosurgery convenience kits because they contain 3M surgical drapes that were previously recalled. The kits were distributed in LA, MO, NC, and FL.
ROi CPS LLC is recalling 21 surgical convenience kits distributed to Louisiana, Missouri, North Carolina, and Florida because they contain 3M surgical drapes that were subsequently recalled.
ROi CPS LLC recalled surgical convenience kits because they contained 3M surgical drapes that were recalled. The specific defect is not described.