FDA (Devices) recall action 84521
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
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.
Datascope is recalling specific lots of Reinforced Introducer Sets due to potential sterility compromise in breached pouches.
Datascope is recalling specific lots of Reinforced Introducer Sets because breached pouches may have compromised sterility.
Datascope is recalling specific lots of Reinforced Introducer Sets because breached pouches may have compromised sterility.