The Recall Desk

FDA (Devices) recall action 75850

Symmetry Surgical, Inc. recalled 3 products on 2017-01-18

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
2017-01-18
Critical
0
Units
7,800

Why these products were recalled

Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain conditions post-sterilization.

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

  • HighFDA (Devices)··2017-01-18

    Symmetry Surgical ULTRA Steam Container Recall for Sealant Defect

    Symmetry Surgical is recalling ULTRA Steam containers because deteriorated or missing base trim sealant may allow contaminants to enter after sterilization.

    Product
    symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C13135, C13136, C13139, C13854, C13855, C13856, C181310, C18134, C18135, C18136, C18138, C22854, C22855, C22856, C22858, C24134, C24135, C24136 Product Usage: sterilization container
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-01-18

    Symmetry Surgical ULTRA Gravity Sterilizer Containers Recalled for Sealant Defect

    Symmetry Surgical is recalling 38 ULTRA Gravity sterilizer containers because deteriorated or missing base trim sealant could allow contaminants to enter the container.

    Product
    symmetry surgical ULTRA(R) Gravity container, REF numbers: C131310-G, C13134-G, C13135-G, C13136-G, C13139-G, C13854-G, C13855-G, C13856-G, C181310-G, C18134-G, C18135-G, C18136-G, C18138-G, C22854-G, C22855-G, C22856-G, C22858-G, C24134-G, C24135-G, C24136-G, C24138, C24138
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-01-18

    Symmetry Surgical ULTRA Sterrad Container Recall for Sealant Defect

    Symmetry Surgical is recalling 149 ULTRA Sterrad containers because deteriorated or missing base trim sealant may allow contaminants to enter the container after sterilization.

    Product
    symmetry surgical ULTRA(R) Sterrad container, REF numbers: C131310-SP, C13134-SP, C13135-SP, C13136-SP, C13139-SP, C13854-SP, C13855-SP, C13856-SP, C181310-SP, C18134-SP, C18135-SP, C18136-SP, C18138-SP, C22854-SP, C22855-SP, C22856-SP, C22858-SP, C24134-SP, C24135-SP, C24
    Category
    Distribution
    0 states