The Recall Desk

FDA (Devices) recall action 75130

Teleflex Medical recalled 2 products on 2016-10-19

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
2016-10-19
Critical
0
Units
320

Why these products were recalled

The product is being recalled due to a labeling error. The Gripper Graspers are labeled as Johans Graspers and the Johans Graspers are labeled as Gripper Graspers.

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)··2016-10-19

    Teleflex Johans Grasper Recall Due to Labeling Error

    Teleflex Medical is recalling 160 Johans Graspers because they were mislabeled as Gripper Graspers. The sterile surgical instruments were distributed to six US states.

    Product
    Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709 The Percutaneous Surgical System with 5 mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the human…
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2016-10-19

    Teleflex Gripper Graspers Recalled for Labeling Error

    Teleflex Medical is recalling 160 Gripper Graspers due to a labeling error where they were mislabeled as Johans Graspers.

    Product
    Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709 The Percutaneous Surgical System with 5 mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the human…
    Category
    Distribution
    6 states