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 sterile convenience kits due to potential open or weak seals on breather pouches used for packaging. The defect 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 Industries is recalling sterile convenience kits due to potential open or weak seals on breather pouches used in packaging. Defective seals may compromise product sterility.
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 multiple sterile convenience kits used for obstetric and gynecological procedures due to potential weak or open seals on breather pouches, which could compromise product sterility.
Medline Industries is recalling multiple convenience kit models due to potential open or weak seals on breather pouches used for packaging. The compromised seals may allow sterility to be compromised on these medical device kits distributed nationwide and internationally.
Medline Industries is recalling sterile convenience kits with select breather pouches that may have open or weak seals, potentially compromising sterility. Affected units were distributed worldwide, including the US, Canada, Mexico, Panama, and the Virgin Islands.
Medline Industries is recalling UNIVERSAL DRAPE PACK convenience kits because their breather pouches may have open or weak seals, potentially compromising sterility of the packaged 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.