The Recall Desk

FDA (Devices) recall action 76298

MEDLINE INDUSTRIES INC recalled 5 products on 2017-05-24

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2017-05-24
Critical
0
Units
3,690

Why these products were recalled

Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possible that the seal on the sterile packaging has been compromised resulting in a loss of sterility of the medical device contained within.

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.

1–5 of 5

  • ModerateFDA (Devices)··2017-05-24

    Medline Recalls Distraction Pins Due to Potential Sterility Loss

    Medline Industries is recalling 2,112 packs of sterile distraction pins because the packaging seal may be compromised, risking loss of sterility.

    Product
    16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fix
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-05-24

    Medline Recalls 10 mm Distraction Pins Due to Sterile Seal Concerns

    Medline Industries is recalling 10 mm Distraction Pins because the sterile packaging seal may be compromised, potentially causing the device to lose sterility.

    Product
    10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fix
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-05-24

    Medline 14 mm Distraction Pin Recalled for Potential Sterility Loss

    Medline Industries is recalling 14 mm Distraction Pins due to potential sterile packaging seal failures that could compromise device sterility.

    Product
    14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-05-24

    Medline 16 mm Distraction Pin Recalled Due to Sterile Seal Integrity

    Medline Industries is recalling 198 packs of 16 mm Distraction Pins because the sterile packaging seal may be compromised, risking loss of sterility.

    Product
    16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixa
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-05-24

    Medline 12 mm Distraction Pin Recalled for Potential Sterility Loss

    Medline Industries is recalling 300 packs of 12 mm Distraction Pins because the sterile packaging seal may be compromised, potentially allowing the device to lose sterility.

    Product
    12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation
    Category
    Distribution
    0 states