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.
Eye surgery convenience kits containing 3M surgical drapes that were separately recalled are being recalled. Affected units were distributed in LA, MO, NC, and FL.
ROi CPS LLC is recalling 18 regard KYPHOPLASTY surgical convenience kits that contained recalled 3M surgical drapes. The kits were distributed to medical facilities in Louisiana, Missouri, North Carolina, and Florida.
ROi CPS LLC is recalling 456 surgical convenience kits containing 3M surgical drapes that were subject to a separate recall. The kits were distributed across Louisiana, Missouri, North Carolina, and Florida.
ROi CPS LLC is recalling 166 Regard Pediatric Urology surgical convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida. The kits contained 3M surgical drapes that were subject to a separate recall.
ROi CPS LLC is recalling 190 units of regard BASIC NEURO surgical convenience kits distributed in LA, MO, NC, and FL. The kits contained 3M surgical drapes that were subsequently recalled.
Surgical convenience kits containing 3M surgical drapes that were subsequently recalled have been pulled from distribution in LA, MO, NC, and FL. Affected lot numbers are 91465 (exp 2/7/2024) and 92444 (exp 5/5/2024).
ROi CPS LLC is recalling 228 gastric surgery convenience kits because they contained 3M surgical drapes that were subsequently recalled. The affected kits were distributed in LA, MO, NC, and FL.
ROi CPS LLC is recalling Regard Retinal Pack surgical kits distributed in Louisiana, Missouri, North Carolina, and Florida because they contained recalled 3M surgical drapes.
Surgical convenience kits (regard NEURO PACK) were recalled because they contain 3M surgical drapes that are subject to a separate recall. Affected units were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida.
Surgical convenience kits are being recalled because they contain 3M surgical drapes that were previously recalled. A total of 164 units were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida.
ROi CPS LLC is recalling 108 surgical convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida that contained 3M surgical drapes which were subsequently recalled.
ROi CPS LLC is recalling 38 neurosurgery convenience kits distributed in four states because they contain 3M surgical drapes that were separately recalled.
Surgical convenience kits are being recalled because they contained 3M surgical drapes that were subsequently recalled. 177 kits distributed in Louisiana, Missouri, North Carolina, and Florida are affected.
ROi CPS LLC is recalling 170 surgical convenience kits containing 3M surgical drapes that were previously recalled. The kits were distributed to medical facilities in Louisiana, Missouri, North Carolina, and Florida.
ROi CPS LLC is recalling regard TOTAL HIP ARTHROPLASTY surgical convenience kits containing recalled 3M surgical drapes distributed to facilities in Louisiana, Missouri, North Carolina, and Florida.
ROi CPS LLC is recalling 790 neuro surgery convenience kits that contained 3M surgical drapes which were subsequently recalled. The kits were distributed to Louisiana, Missouri, North Carolina, and Florida.
Orthopedic surgical convenience kits distributed in four states were recalled because they contain 3M surgical drapes that were subject to a separate recall.
ROi CPS LLC is recalling 302 Regard SPINE surgical convenience kits containing 3M surgical drapes that were subject to an FDA recall. Affected kits were distributed in Louisiana, Missouri, North Carolina, and Florida.
ROi CPS LLC is recalling 54 regard LATERAL SHOULDER surgical convenience kits containing 3M surgical drapes that were subsequently recalled by the manufacturer. Affected kits were distributed to facilities in Louisiana, Missouri, North Carolina, and Florida.
ROi CPS LLC is recalling 326 regard TOTAL JOINT surgical convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida. The kits contain 3M surgical drapes that were previously recalled. No illnesses or injuries have been reported.
Orthopaedic surgical convenience kits distributed in four states contained 3M surgical drapes that were subsequently recalled. ROi CPS LLC is recalling 38 affected kits.
Cataract eye surgery convenience kits containing recalled 3M surgical drapes were distributed to four states. ROi CPS LLC has recalled 780 units of the regard CATARACT product.
Regard ACDF surgical convenience kits containing 3M surgical drapes that were subsequently recalled are being recalled by ROi CPS LLC. Approximately 30 kits were distributed in Louisiana, Missouri, North Carolina, and Florida.
Regard VITRECTOMY PK surgical convenience kits are being recalled because they contain 3M surgical drapes that were separately recalled. Affected kits were distributed in Louisiana, Missouri, North Carolina, and Florida.
ROi CPS LLC is recalling 258 surgical convenience kits containing 3M surgical drapes that were subject to a subsequent recall. The kits were distributed in Louisiana, Missouri, North Carolina, and Florida.