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Ethicon, Inc. recalls Coated VICRYL RAPIDETM (Polyglactin 910) Suture
Recalled March 7, 2018 · FDA recall Z-0693-2018 · Ethicon
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. · FDA Class II
Units
129,372 Eaches (Internationally)
Sold at
Nationally
Description
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.
Product
Coated VICRYL RAPIDETM (Polyglactin 910) Suture
Manufacturer(s)
Ethicon, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →