The Recall Desk

FDA (Devices) recall action 73115

Covidien LLC recalled 2 products on 2016-03-09

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
2016-03-09
Critical
0
Units
2,340

Why these products were recalled

8FR 16 PVC tubes were packaged in a 6.5 FR 36 Polyurethane packs and 8FR 20 PVC tubes were packaged in an 8FR 20 Polyurethane packs

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

  • ModerateFDA (Devices)··2016-03-09

    FDA Recalls Mispackaged Pediatric Feeding Tubes Due to Labeling Error

    The FDA is recalling 1,010 units of pediatric feeding tubes because 8FR PVC tubes were incorrectly packaged in 6.5FR polyurethane packs.

    Product
    Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch (2.2 mm) x 36" (91 cm), Sterile; Catalog Number: 461438. Intended for pediatric feeding.
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2016-03-09

    FDA Recalls Mispackaged Pediatric Feeding Tubes from Covidien

    The FDA is recalling 1,330 units of pediatric feeding tubes due to packaging errors where different tube sizes were placed in incorrect packages.

    Product
    Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 8 Fr/Ch (2.7 mm) x 20" (51 cm); Catalog Number: 461701. Intended for pediatric feeding.
    Category
    Distribution
    1 state