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Covidien, LP Recall 90362

Description: EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.

Covidien, LP Recall 90362 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1322-2022
Event ID90362
Event DescriptionEEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.
Product TypeDevices
DistributionWorldwide distribution - US Nationwide.
Quantity433,560
Recall ReasonThe affected staplers have the potential for the staple guide to not be securely attached to the instrument. The issue could cause the component to disengage and if disengaged, could allow the device to transect tissue without forming staples.
Device Classification20220713
Device Code InfoUDI-DI (GTIN): 10884523004731 10884523004748 10884523006056 10884523006124 Lots P0A1388KY P0A1389KSY P0A1497KY P0A1498KSY P0B1081KY P0B1082KY P0B1083KSY P0B1188KY P0B1189KY P0B1339KY P0B1340KY P0B1460KY P0B1461KY P0B1462KY P0B1494KY P0B1495KY P0B1496KY P0C1183KY P0C1344KY P0C1345KY P0C1346KSY P0C1544KSY P0D0105KY P0D0106KY P0D1244KY P0D1313KY P0D1314KY P0D1315KY P0D1412KY P0D1413KY P0D1415KSY P0E0004KY P0E0005KY P0E1255KSY P0E1273KY P0E1274KY P0E1275KY P0E1276KY P0E1387KSY P0F0198KY P0F0199KY P0F0450KY P0F0451KY P0F0452KY P0F0836SY P0F0837SY P0G0041SY P0G0042SY P0G0063SY P0G0432Y P0G0433Y P0G0539Y P0G0540Y P0G0541Y P0G0644SY P0G0645SY P0H0014SY P0H0015SY P0H0016SY P0H0230Y P0H0377SY P0H0404SY P0H0405SY P0H0460SY P0J0002SY P0J0136Y P0J0462Y P0J0540SY P0J0546Y P0J0569Y P0J0570Y P0K0240Y P0L1268 P0L1346S P0L1416 P0M0890 P0M1733 P1A1129 P1C1850 P1E0212 P1F1430 P1F1573 P1G0777 P1G1144 P1J0290 P1J1366 P1K0352 P1K0960 P1K1271 P1K1303 P1K1316 P1L0163 P7A0912KX P7A0913KX 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P9E1116KY P9E1117KY P9E1312KY P9E1313KY P9F1227KY P9F1228KY P9H0669KY P9H0670KY P9H0963KY P9H0964KY P9J1008KY P9J1234KY P9J1235KY P9M1412KY P9M1486KY
Center Classification Date20220701
Recall Initiation Date20220513
Recalling FirmCovidien, LP
Initial Notification Letter
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