Device product
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.
Z-1839-2015
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 71373
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,922 units
- Official record key
device-enforcement:Z-1839-2015
Official wording
Reason: Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the box and foil are incomplete.
Code information: 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.
Distribution pattern: Worldwide Distribution -- US (nationwide) and Canada.
Derived failure modes
-
Labeling or packaging
labeling on the box and foil are incomplete