ES0120, AEM Disposable Low Profile Scissors, 3/4", 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures
This recall has been terminated (originally issued May 31, 2011).
- Company
- Encision, Inc.
- Recall Initiated
- April 7, 2011
- Posted
- May 31, 2011
- Terminated
- August 9, 2011
- Recall Number
- Z-2398-2011
- Quantity
- 233 Ten Count Boxes, 1 Kit
- Firm Location
- Boulder, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Sterility may be compromised due to holes in packaging.
Distribution
Worldwide Distribution - USA (nationwide) and the countries of Australia and New Zealand
Lot / Code Info
Lot # QJQ, QKE, QKG, QLD, RAH, RBE
Root Cause
Package design/selection
Action Taken
Encision, Inc. sent an Important Safety Notice letter dated April 7, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to either carefully inspect any remaining pouches for readily visible holes in the Tyvek pouch, or return the affected lots to Encision for inspection. Customers were also asked to fill in and fax back the attached Confirmation to 303-444-2693.