FDA (Devices) recall action 95415
The FDA (Devices) publishes a recall like this one as 33 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 33 pages.
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
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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 is recalling certain Centurion tracheostomy kits due to potential non-sterility if the packaging seal is compromised. The affected kits may allow non-sterile product use.
Medline IV TEAM PICC medical procedure kits may contain non-sterile product if the breather pouch vendor seal has been opened. The recall affects 120 units distributed worldwide including the US, Canada, and Panama.
Medline medical procedure convenience kits with certain breather pouches may lose sterility if the vendor seal is opened. Approximately 5,972 units were distributed in the US, Canada, and Panama.
Medline is recalling certain convenience kits for medical procedures due to potential non-sterile product risk if the breather pouch seal is compromised. The recall affects 51 units distributed in the US, Canada, and Panama.
Medline recalled pediatric drape kits that may become non-sterile if the pouch seal is compromised. Affected units were distributed in the US, Canada, and Panama.
Medline is recalling specific medical procedure convenience kits because a packaging defect could allow the use of non-sterile products if the vendor seal is opened.
Medline is recalling 15 CV Anesthesia Room Setup kits because a packaging defect may allow non-sterile product use if the pouch seal is opened.
Medline is recalling 168 Centurion medical procedure kits because packaging defects may allow non-sterile product use if the vendor seal is compromised.