Recall Z-1702-2015
Alcon Research, Ltd. · initiated April 28, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove.
Codes / lots: 1367627H 1367700H 1370468H 1374839H 1377749H 1378861H 1381718H 1381790H 1384702H 1386455H 1387943H 1388009H 1388010H 1388166V 1388511H 1388512H 1388513H 1389356H 1389471H 1389472H 1390944H 1391983H 1393363H 1393364H 1393610H 1396053H 1399825H 1401814H 1402528V 1403164H 1403821H 1405058H 1408045H 1409183H 1409851H 1415212H 1419278H 1419338H 1421822H 1425061H 1425803H 1428919H 1430191H 1430728H 1430754H 1430755H 1431698H 1433391H 1434865H 1434953H 1435810H 1441247H 1444893H 1445803V 1446438H 1446497H 1447083H 1447480H 1449115V 1451237H 1451787H 1456506H 1456809H 1457967H 1460058H 1463012H 1463152H 1463308H 1463395H 1464333H 1464505H 1464902H 1466086H 1466240H 1466495H 1466496H 1469343H 1469571H 1470568V 1470948H 1472070H 1475160H 1475161H 1475597H 1476584H 1477332H 1477581H 1477752H 1477789H 1480137H 1480257H 1480467H 1481877H 1483926H 1485422H 1485722H 1486478H 1487040H 1488898H 1490193H 1491469H 1494604H 1494975H 1497536H 1497607H 1498335H 1498787H 1499119V 1499177V 1499713H 1500764H 1500937H 1501079H 1501126H 1501347H 1501960H 1503259H 1503266H 1503483H 1504431H 1507406H 1507738H 1508991H 1509297H 1509499H 1509675H 1509769H 1510006H 1510111H 1510287H 1510377H 1510398H 1510883H…
Reason for recall
The supplier of the Devon Light Glove, a component of the Alcon Custom PAK, recalled the gloves due to the potential for splits and holes on the glove. Should the user be unaware that the Light Glove is torn/split, surgical site infections are possible.
FDA-determined cause: Nonconforming Material/Component
Action taken
Alcon sent a Recall letter dated April 28, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter included a return form and instructions for credit. Customers were instructed to review inventory for any affected units, segregat the product to ensure it is not used, and return the attached Response Form via fax or email to Alcon. For questions or need assistance with obtaining replacement products contact Alson Customer service at 800-862-5266.
Details
- Recall number
- Z-1702-2015
- Initiated
- April 28, 2015
- Posted by FDA
- June 9, 2015
- Terminated
- March 24, 2016
- Product code
- LRO – General Surgery Tray
- Quantity
- 219,680 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Australia and Canada.
- Recalling firm
- Alcon Research, Ltd., Fort Worth, TX