Enseal TRIO Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05

FDA device recall Z-2635-2010 · posted 2010-09-30 · Terminated

Recall details

Recalling firm

Ethicon Endo-Surgery Inc

Reason for recall

The weld that connects the electrode to the active rod was separated. This connection is critical to the proper function of these devices. If the weld is separated, the product will not deliver energy to the jaws, resulting in the potential for a cut/transection without a seal. Ethicon Endo-Surgery identified this issue during a routine finished goods quality inspection.

Action taken

Ethicon Endo-Surgery issued an Urgent: Device Recall, Event 2193 letter dated July 19, 2010 identifying the affected device, the issue prompting the recall, and actions to be taken by consignees. Consignees were instructed: Do not use the affected product. Identify and quarantine affected product from inventory. Complete the Business Reply form and fax to Stericycle at 877-597-9580 within three days To return product, place it in a box with a copy of the Business Reply form and mail to Stericycle using the pre-printed UPS shipping label. Replacement product should be received by the customer within 60 days of return of affected product. Customers can contact Stericycle about this recall at 877-243-7314 and referencing Event 2193.

Root cause

Other

Status

Terminated

Product code

NLM

Quantity affected

396 instruments

Distribution

Nationwide Distribution to the following states: AZ, AL, AZ, CA, CO, CT, FL, GA, IN, KY, MA, MD, MI, MO, MS, NC, NV, NY, OH, PA, TN, TX, WA, and WV.

Date initiated

2010-07-09

Date posted

2010-09-30

Date terminated

2011-02-14

Location

Cincinnati, OH

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