Coated VICRYL RAPIDETM (Polyglactin 910) Suture
Reported: March 7, 2018 Initiated: August 17, 2017 #Z-0693-2018
Product Description
Coated VICRYL RAPIDETM (Polyglactin 910) Suture
Reason for Recall
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.
Details
- Recalling Firm
- Ethicon, Inc.
- Units Affected
- 129,372 Eaches (Internationally)
- Distribution
- Nationally
- Location
- Somerville, NJ
Frequently Asked Questions
What product was recalled? ▼
Coated VICRYL RAPIDETM (Polyglactin 910) Suture. Recalled by Ethicon, Inc.. Units affected: 129,372 Eaches (Internationally).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 7, 2018. Severity: Moderate. Recall number: Z-0693-2018.
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