FDA (Devices) recall action 97877
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
The impacted lot may not meet the required tensile strength specification.
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.
Glycar SA is recalling 18 SJM Pericardial Patches, 5 x 10 cm, because the impacted lot may not meet the required tensile strength specification. The FDA classified it Class I.
Glycar SA is recalling 30 SJM Pericardial Patches with EnCap Technology because the impacted lot may not meet the required tensile strength specification. The FDA classified it Class I.