The Recall Desk

FDA (Devices) recall action 68721

Peters Surgical recalled 2 products on 2014-10-01

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2014-10-01
Critical
0
Units
27,166

Why these products were recalled

A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified.

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.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2014-10-01

    Peters Surgical Recalls CARDIOXYL Sutures Due to Surface Treatment Splitting

    Peters Surgical is recalling 4,976 units of CARDIOXYL synthetic surgical sutures because a potential splitting of the surface treatment on thread ends was identified.

    Product
    The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with polysiloxane. CARDIOXYL sutures are green dyed (D&C green # 6, CI 61565) and…
    Category
    Distribution
    19 states
  • HighFDA (Devices)··2014-10-01

    Peters Surgical Recalls CARDIOFLON Evolution Sutures for Surface Splitting

    Peters Surgical is recalling 22,190 units of CARDIOFLON Evolution sutures due to a potential splitting of the surface treatment on thread ends.

    Product
    The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate)] braids, coated, with or without PLEDGETS of different sizes. CARDIOFLON Evolution sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some…
    Category
    Distribution
    19 states