The Recall Desk

FDA (Devices) recall action 82420

Ethicon, Inc. recalled 3 products on 2019-04-24

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2019-04-24
Critical
0
Units
1,652,043

Why these products were recalled

VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • ModerateFDA (Devices)··2019-04-24

    Ethicon Recalls VICRYL Plus Sutures Due to Labeling Mismatches

    Ethicon, Inc. is recalling VICRYL Plus Sutures because the product may not match the sales unit carton and foil label.

    Product
    VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 UND VICRYL PLUS SUTURE 18"(45CM) 0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 VIO) VICRYL PLUS SUTURE 18"(45CM) 1 VIO VICRYL PLUS SUTURE 18"(45CM) 4-0 VIO VICRYL PLUS SUTURE 27"(70CM) 3-0…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-04-24

    Ethicon Recalls VICRYL and PDS Sutures Due to Labeling Mismatches

    Ethicon, Inc. is recalling VICRYL, VICRYL Plus, and PDS sutures because the product inside may not match the sales unit carton and foil label.

    Product
    PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS II suture is not indicated in adult cardiovascular…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-04-24

    Ethicon Recalls VICRYL Sutures Due to Labeling Mismatch

    Ethicon, Inc. is recalling VICRYL, VICRYL Plus, and PDS sutures because the product may not match the sales unit carton and foil label.

    Product
    VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL CT VIO 8X18IN 0 S/A CT-1 CR VICRYL SUTURE 18"(45CM) 1 VIO VCL CT UD 8X18IN 2-0 S/A CP-2 CR…
    Category
    Distribution
    0 states