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 50 units of curved pean forceps kits because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 40 units of CHS Custom Convenience Kit-INJECTION TRAY because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 160 units of CHS Custom Convenience Kit-PAD, COTTON SINGLE because incorrect sealing specifications compromised product sterility.
Custom Healthcare Systems is recalling 60 units of CHS Custom Convenience Kits because incorrect sealing specifications compromised product sterility.