FDAFDA · Food and drugs·Recall number Z-1839-2015
Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. Fast absorbing surgical gut suture is a strand of collagenous material prepared from the submucosal layers of the small intestine of healthy sheep, or from the serosal layers of the small intestine of healthy cattle. Fast absorbing surgical gut sutures are sterile and elecit only a slight to minimal tissue reaction during absorption.
Published July 1, 2015 · Recall initiated: May 8, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the box and foil are incomplete.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ethicon, Inc.
- Distributor
- Worldwide Distribution -- US (nationwide) and Canada.
- Lot
- Product Code: 1915G (box label); 1915 (Tyvek/Foil label) Product Lot #'s JC6395, JC6417, JCK328, JCK329, JCK384, JCK716, JCM669, JCM757, JCZ987, JC5020, JC6710, JCM535, JCK330, JCK460, JCM668, JC5629 and JCM475.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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