FDA (Devices) recall action 96510
The FDA (Devices) publishes a recall like this one as 34 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 34 pages.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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 is recalling select Intubation Tray convenience kits (Model MNS10395, Lot 24KBI045) due to potential open or weak seals on breather pouches used for packaging. Weak seals may compromise product sterility.
Medline Industries is recalling multiple sterile surgical convenience kits because purchased breather pouches used in packaging may have open or weak seals, which could compromise sterility.
Medline is recalling select NAIL PACK sterile convenience kits (Model SUT15830A, Lot 24IBR642) due to potential open or weak seals on breather pouches used for product packaging.
Medline Industries is recalling multiple sterile procedure kits due to potential open or weak seals on breather pouches used for packaging. The affected kits were distributed worldwide including the US and several other countries.
Medline Industries is recalling select sterile convenience kits (Model DYNJ80807B, Lot 24IBH993) due to potential open or weak seals on breather pouches used for packaging. Compromised seals may affect product sterility.
Medline Industries is recalling Rhinoplasty Pack convenience kits (Model DYNJ84116A, Lot 24IBH580) due to potential open or weak seals on breather pouches used for packaging. Compromised packaging may affect sterility of the sterile kits.
Medline Industries is recalling 21,935 units of sterile convenience kits used for labor, delivery, and vaginal delivery procedures due to potential open or weak seals on breather pouches. The defective packaging could compromise product sterility.
Medline is recalling five models of dental convenience kits due to the potential for open or weak seals on the breather pouches used for packaging. The affected sterile kits were distributed nationwide in the US and internationally.
Medline Industries is recalling select sterile convenience kits due to potential open or weak seals on breather pouches used for packaging. The issue affects 116 units distributed worldwide.