ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Straight Jaw, Model # NSLG2S14 and ENSEAL 5 mm Diameter Tissue Sealer

FDA device recall Z-1246-2012 · posted 2012-03-21 · Terminated

Recall details

Recalling firm

Ethicon Endo-Surgery Inc

Reason for recall

Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENSEAL G2 Curved and Straight Tissue Sealers due to two potential issues that may occur related to the activation button: (i) Continuous Activation: The ENSEAL device/system may continue to activate when the activation button is released prior to reaching the end of cycle (tone 3). (ii) No Activation

Action taken

Ethicon Endo-Surgery sent an Urgent Medical Device Recall letter dated February 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop use of the affected product, fill out the attached Business Reply Form (BRF) and return to and return the affected product to: Ethicon Endo-Surgery ATT: ENSEAL G2 Recall 4545 Greek Road Cincinnati, Ohio 45242 Customers were instructed to choose one of the following response options: Return the Business Reply Form to their sales representative Call 1-800-873-3636, Option 6 Fax the BRF to 1-513-337-4138 For any questions regarding this recall call 513-337-3419.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LFL

Quantity affected

84 pieces

Distribution

Worldwide Distribution - USA including AZ, CA, CT, FL, IL, IN, KS, KY, MA, MI, MO, NC, NY, OH, PA, TN & TX and the countries of Arab Emirates, Austria, Belgium, France, Germany, Great Britain, Italy,

Date initiated

2012-01-26

Date posted

2012-03-21

Date terminated

2013-02-15

Location

Cincinnati, OH

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