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Ethicon Fast Absorbing Plain Gut - MultiPass Needles… recallZ-1839-2015 · Ethicon, Inc. · initiated May 8, 2015

Class II Terminated All recalls posted in June 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ethicon, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the box and foil are incomplete.

FDA root cause category: Labeling mix-ups

What the company is doing

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.

Recall details

Recall number
Z-1839-2015
Recall class
Class II
Status
Terminated
Initiated by the company
May 8, 2015
Posted by the FDA
Jun 25, 2015
Recalling firm
Ethicon, Inc.
Quantity
1,922 units
Product code
GAL
FDA submissions
K946173
Distribution
Worldwide Distribution -- US (nationwide) and Canada.

Product description

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.

Code information (models, lots, serial numbers)

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.

Other devices under the same FDA submission

457 devices cleared under K946173 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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