Reported Jun 10, 2015 · Terminated
The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by…
Alcon Research, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alcon Research, Ltd. · 6201 South Fwy · Fort Worth, TX · 76134-2099
Is this the product you have?
- 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.
- Lot codes and dates
746 of 746 codes
1367627H1367700H1370468H1374839H1377749H1378861H1381718H1381790H1384702H1386455H1387943H1388009H1388010H1388166V1388511H1388512H1388513H1389356H1389471H1389472H1390944H1391983H1393363H1393364H1393610H1396053H1399825H1401814H1402528V1403164H1403821H1405058H1408045H1409183H1409851H1415212H1419278H1419338H1421822H1425061H1425803H1428919H1430191H1430728H1430754H1430755H1431698H1433391H1434865H1434953H1435810H1441247H1444893H1445803V1446438H1446497H1447083H1447480H1449115V1451237H
- Amount recalled
- 219,680 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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