FDA-Device2018-03-07Class II
Coated VICRYL RAPIDETM (Polyglactin 910) Suture
Ethicon, Inc.
Hazard
On August 17, 2017, Ethicon had decided to initiate a medical device recall (removal) of the twenty-five (25) lots of VICRYL RAPIDETM (Polyglactin 910) Suture that were distributed to the field. During finished goods testing, a suture damage was identified on a lot of VICRYL RAPIDETM Suture. During the course of the subsequent investigation, the suture also failed knot tensile strength testing.
Sold states
Nationally
Affected count
129,372 Eaches (Internationally)
Manufactured in
Us Highway 22 West, N/A, Somerville, NJ, United States
Products
Coated VICRYL RAPIDETM (Polyglactin 910) Suture
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0693-2018Don't want to check this manually?
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