🔍 RecallPedia

Coated VICRYL RAPIDETM (Polyglactin 910) Suture

Class I - Dangerous
🏥 Medical Devices Recalled: August 17, 2017 Ethicon Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Coated VICRYL RAPIDETM (Polyglactin 910) Suture MPVR4260H Size 4-0 VICRYL RAPIDE Undyed 75cm PS-2 Needle 10705031149168 Coated VICRYL RAPIDETM (Polyglactin 910) Suture V2140H Size 4-0 VICRYL RAPIDE Undyed 70cm RB-1 Needle 10705031106048 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2217 Size 2-0 VICRYL RAPIDE Undyed 90cm V-34 Needle 10705031119925 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2253 Size 2-0 VICRYL RAPIDE Undyed 75cm FS-1 Needle 10705031119956 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2279 Size 4-0 VICRYL RAPIDE Undyed 75cm V-4 Needle 10705031086524 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2294 Size 4-0 VICRYL RAPIDE Undyed 75cm FS-3 Needle 10705031086548 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2297 Size 4-0 VICRYL RAPIDE Undyed 75cm FS-2 Needle 10705031119970 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR496 Size 4-0 VICRYL RAPIDE Undyed 18'' PS-2 Needle 10705031134690 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR945 Size 2-0 VICRYL RAPIDE Undyed 36'' CT-1 Needle 10705031133358 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VRI253H Size 2-0 VICRYL RAPIDE Undyed 75cm FS-1 Needle 10705031111172 Coated VICRYL RAPIDETM (Polyglactin 910) Suture W9941 Size 2-0 VICRYL RAPIDE Undyed 75cm FS Needle 10705031130999 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR426 Size 4-0 VICRYL RAPIDE Undyed 75cm PS-2 Needle 10705031134669 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR494 Size 4-0 VICRYL RAPIDE Undyed 45cm P-3 Needle 10705031134683 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR845 Size 4-0 VICRYL RAPIDE Undyed 45cm PC-3 Needle 10705031134744 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR917 Size 2-0 VICRYL RAPIDE Undyed 90cm V-34 Needle 10705031134768 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2286 Size 2-0 VICRYL RAPIDE Undyed 90cm FSL Needle 10705031080256 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2299 Size 2-0 VICRYL RAPIDE Undyed 75cm FS-2 Needle 10705031080294 Coated VICRYL RAPIDETM (Polyglactin 910) Suture W9918 Size 4-0 VICRYL RAPIDE Undyed 75cm PC-3 Needle 10705031151970 Coated VICRYL RAPIDETM (Polyglactin 910) Suture W9930 Size 4-0 VICRYL RAPIDE Undyed 75cm FS-2 Needle 10705031152007 Coated VICRYL RAPIDETM (Polyglactin 910) Suture FH1642H Size 4-0 VICRYL RAPIDE Undyed 45cm FS-2 Needle 10705031099968 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VRI214H Size 4-0 VICRYL RAPIDE Undyed 75cm RB-1 Plus Needle 10705031111127 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VRI312H Size 2-0 VICRYL RAPIDE Undyed 75cm SH-1 Plus Needle 10705031111264 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VRI417H Size 2-0 VICRY RAPIDE Undyed 75cm SH Plus Needle 10705031111332 Coated VICRYL RAPIDETM (Polyglactin 910) Suture W9922 Size 4-0 VICRYL RAPIDE Undyed 75cm PS-2 Needle 10705031130845 Coated VICRYL RAPIDETM (Polyglactin 910) Suture W9933 Size 2-0 VICRYL RAPIDE Undyed 75cm PS Needle 10705031130937
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Ethicon, Inc.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Coated VICRYL RAPIDETM (Polyglactin 910) Suture

Product Codes/Lot Numbers:

Coated VICRYL RAPIDETM (Polyglactin 910) Suture MPVR4260H Size 4-0 VICRYL RAPIDE Undyed 75cm PS-2 Needle 10705031149168 Coated VICRYL RAPIDETM (Polyglactin 910) Suture V2140H Size 4-0 VICRYL RAPIDE Undyed 70cm RB-1 Needle 10705031106048 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2217 Size 2-0 VICRYL RAPIDE Undyed 90cm V-34 Needle 10705031119925 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2253 Size 2-0 VICRYL RAPIDE Undyed 75cm FS-1 Needle 10705031119956 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2279 Size 4-0 VICRYL RAPIDE Undyed 75cm V-4 Needle 10705031086524 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2294 Size 4-0 VICRYL RAPIDE Undyed 75cm FS-3 Needle 10705031086548 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2297 Size 4-0 VICRYL RAPIDE Undyed 75cm FS-2 Needle 10705031119970 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR496 Size 4-0 VICRYL RAPIDE Undyed 18'' PS-2 Needle 10705031134690 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR945 Size 2-0 VICRYL RAPIDE Undyed 36'' CT-1 Needle 10705031133358 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VRI253H Size 2-0 VICRYL RAPIDE Undyed 75cm FS-1 Needle 10705031111172 Coated VICRYL RAPIDETM (Polyglactin 910) Suture W9941 Size 2-0 VICRYL RAPIDE Undyed 75cm FS Needle 10705031130999 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR426 Size 4-0 VICRYL RAPIDE Undyed 75cm PS-2 Needle 10705031134669 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR494 Size 4-0 VICRYL RAPIDE Undyed 45cm P-3 Needle 10705031134683 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR845 Size 4-0 VICRYL RAPIDE Undyed 45cm PC-3 Needle 10705031134744 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR917 Size 2-0 VICRYL RAPIDE Undyed 90cm V-34 Needle 10705031134768 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2286 Size 2-0 VICRYL RAPIDE Undyed 90cm FSL Needle 10705031080256 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2299 Size 2-0 VICRYL RAPIDE Undyed 75cm FS-2 Needle 10705031080294 Coated VICRYL RAPIDETM (Polyglactin 910) Suture W9918 Size 4-0 VICRYL RAPIDE Undyed 75cm PC-3 Needle 10705031151970 Coated VICRYL RAPIDETM (Polyglactin 910) Suture W9930 Size 4-0 VICRYL RAPIDE Undyed 75cm FS-2 Needle 10705031152007 Coated VICRYL RAPIDETM (Polyglactin 910) Suture FH1642H Size 4-0 VICRYL RAPIDE Undyed 45cm FS-2 Needle 10705031099968 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VRI214H Size 4-0 VICRYL RAPIDE Undyed 75cm RB-1 Plus Needle 10705031111127 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VRI312H Size 2-0 VICRYL RAPIDE Undyed 75cm SH-1 Plus Needle 10705031111264 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VRI417H Size 2-0 VICRY RAPIDE Undyed 75cm SH Plus Needle 10705031111332 Coated VICRYL RAPIDETM (Polyglactin 910) Suture W9922 Size 4-0 VICRYL RAPIDE Undyed 75cm PS-2 Needle 10705031130845 Coated VICRYL RAPIDETM (Polyglactin 910) Suture W9933 Size 2-0 VICRYL RAPIDE Undyed 75cm PS Needle 10705031130937

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0693-2018

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Ethicon

Class I - Dangerous

Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

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