Recall Z-1839-2015
Ethicon, Inc. · initiated May 8, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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.
Reason for recall
Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the box and foil are incomplete.
FDA-determined cause: Labeling mix-ups
Action taken
Ethicon initiated this voluntary recall by sending an Urgent: Medical Device Recall (Removal) Letter/Business Reply Form (BRF) dated May 8, 2015 to their affected customers via UPS. Stericycle will be handling returns. The letters identified the affected device and the reason for the recall. Customers were asked to examine their inventory immediately to determine if they had affected devices on hand. If so, they are to remove the affected product and communicate the issue to any necessary personnel. Customers with questions were advised to contact their local sales representative or call the Customer Support Center at 1-877-384-4266. For questions regarding this recall call 908-218-0707.
Details
- Recall number
- Z-1839-2015
- Initiated
- May 8, 2015
- Posted by FDA
- June 25, 2015
- Terminated
- June 6, 2017
- Product code
- GAL – Suture, Absorbable, Natural
- Quantity
- 1,922 units
- Distribution
- Worldwide Distribution -- US (nationwide) and Canada.
- Recalling firm
- Ethicon, Inc., Somerville, NJ