FDA (Devices) recall action 88268
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
The kits may contain an expired component.
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 286 knee arthroscopy kits containing an expired NaCl irrigation bag. The kits should not be used due to the expired component.
Medline Industries is recalling Total Knee convenience kits that may contain an expired saline irrigation solution component. The expired component may not maintain proper sterility for surgical use.
Medline Industries is recalling 286 Arthroscopy Kits (REF DYNJ904304B) containing an expired NaCl irrigation bag component. The affected kits were distributed to Minnesota, Nebraska, and Pennsylvania.
Medline Industries is recalling 286 Shoulder CDS convenience kits that may contain an expired NaCl irrigation component. Users should stop using the kits and contact the manufacturer for return instructions.