FDA-Device2017-11-15Class II
WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO
Teleflex Medical
Hazard
The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier.
Sold states
Nationwide and Australia, Canada, Singapore, Thailand, China, Taiwan, Belgium, Japan, S. Korea
Affected count
13,710 units
Manufactured in
2917 Weck Dr, N/A, Research Triangle Park, NC, United States
Products
WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0083-2018Don't want to check this manually?
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