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 312 medical procedure convenience kits due to potential sterility issues if the breather pouch seal is opened or damaged. The affected kits were distributed in the US, Canada, and Panama.
Medline brand medical procedure convenience kits packaged in breather pouch lot 323080002 may be non-sterile if the vendor seal is opened or compromised. Affected kits are distributed in the US, Canada, and Panama.
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 is recalling 194 drape packs from breather pouch lot 323080002 that may be non-sterile if the seal is opened. The kits were distributed in 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 medical procedure kits packaged in breather pouch lot 323080002 because seals may not prevent non-sterile product use. Affected units were distributed in the US, Canada, and Panama.
Medline CENTRAL CATHETER INSERTION KIT (Ref CVI680C) is being recalled because certain units may be non-sterile due to potential seal failures in packaging. The recall affects 1,180 units distributed in the US, Canada, and Panama.
Medline is recalling 160 units of EYE PACK medical procedure kits due to potential compromises in sterilization. If the vendor seal on the breather pouch is opened or unsealed, the contents may become non-sterile.
Medline is recalling certain Ambulatory Mini Pack convenience kits from lot 23LBO804 because they may be non-sterile if the vendor seal on the breather pouch is opened or unsealed.
Medline is recalling certain medical procedure convenience kits due to a breather pouch seal defect. If the pouch seal is opened or compromised, the product may not be sterile and could pose a health risk during surgical use.
Medline Industries recalls 22,327 units of medical procedure convenience kits distributed in the US, Canada, and Panama. The FDA Class II recall affects multiple kit variants and is currently ongoing.
Medline Industries is recalling 2,740 surgical convenience kits with breather pouches that may result in non-sterile product if the vendor seal is opened. The recall affects 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 90 units of its dialysis convenience kit due to potential non-sterile product if the package seal is compromised. Affected units were distributed in the US, Canada, and Panama.
Medline is recalling 8,830 medical procedure convenience kits with potential breather pouch seal failure that could allow non-sterile product use.
Medline is recalling approximately 1,048 medical procedure convenience kits that may become non-sterile if their protective pouch seal is compromised. The affected kits were packaged with breather pouches from lot 323080002.
Medline is recalling certain tubal ligation procedure kits due to potential loss of sterility if the pouch seal becomes compromised during storage or handling.
Medline is recalling 88 convenience kits used in gynecological medical procedures due to potential non-sterility if the breather pouch seal is compromised. The affected lots are distributed in the US, Canada, and Panama.
Medline brand obstetric convenience kits packaged in breather pouch lot 323080002 may become non-sterile if the vendor seal is opened or unsealed.
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's Centurion OB TRAY convenience kits with breather pouch lot 323080002 may be non-sterile if the pouch seal is opened or becomes unsealed, posing a risk in obstetric procedures.
Medline medical procedure kits may contain non-sterile product if the breather pouch seal is opened or compromised. The recall affects 320 units distributed in the US, Canada, and Panama.
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 Industries is recalling 90 units of Centurion EP LAB INSTRUMENT KIT convenience kits from lot 23LBK889. The kits may contain non-sterile product if the breather pouch vendor seal is opened or compromised.
Medline is recalling 2,371 medical procedure convenience kits because certain kits packaged in specific breather pouches may contain non-sterile product if the seal is compromised.