FDA (Devices) recall action 81179
The FDA (Devices) publishes a recall like this one as 29 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 29 pages.
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
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.
Custom Healthcare Systems is recalling Webster Needle Holder Convenience Kits because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 89 units of surgical gowns and convenience kits because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 24 units of Penrose Drain Convenience Kits because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 1,250 suture removal kits because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling specific lots of CHS Custom Convenience Kits because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 630 CHS Custom Convenience Kits because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 100 units of toothbrush kits because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 250 units of 22G LP Needle Convenience Kits because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 200 units of CHS Custom Convenience Kits because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 48 units of Suture Removal Kit #1 because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 50 units of Mosquito Forceps kits because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 300 Little Snipper Circumcision Trays because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 7,200 surgical gown kits because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 48 units of Bone Marrow Tray Convenience Kits because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 50 units of Foerster Sponge Forceps kits because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 4,500 fenestrated drape kits because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 72,832 units of convenience gowns because they were sealed with incorrect specifications, compromising sterility.
Custom Healthcare Systems is recalling 100 units of convenience kits because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 150 units of CHS Custom Convenience Kit-CONNECTOR PACK due to incorrect sealing specifications that compromised product sterility.
Custom Healthcare Systems is recalling 30 units of cast padding kits because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 150 units of Formula Cap Convenience Kits because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 80 units of Toenail Removal Kits because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling vaginal speculums because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 150 units of CHS Cotton Tip Applicators because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 150 units of COBAN Convenience Kits because incorrect sealing specifications compromised product sterility.