Mitek VAPR Temperature Control Electrode (integrated Product Code: 227252 The VAPR Electrodes (end effect, side effect,

FDA device recall Z-2309-2010 · posted 2010-08-27 · Terminated

Recall details

Recalling firm

DePuy Mitek, Inc., a Johnson & Johnson Co.

Reason for recall

Product does not meet the packaging specifications for pouch seal integrity which could lead to a breach in sterility

Action taken

The firm, Depuy Mitek, sent an "Urgent Voluntary Product Recall" letter dated June 7, 2010, to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to not use any of the identified recalled products; to isolate all inventory of the affected product; complete the Business Reply Form, and return the affected products along with the form to Depuy Mitek; ATTN: Recall Coordinator, 50 Scotland Boulevard, Bridgewater, MA 02324 or fax completed form to 1-508-828-3750. Note the IMPORTANT PRODUCT INFORMATION: Any product that contains a round green sticker has been 100% inspected, meets specifications and is acceptable for use. Please Do Not Return any product that is labeled with the green dots because this product is not affected by the recall. If you have any questions or concerns with regard to this program, please contact your local Depuy Mitek Representative or DePuy Mitek Customer Service directly at 1-800-382-4682.

Root cause

Packaging process control

Status

Terminated

Product code

GEI

Quantity affected

1414 units

Distribution

Worldwide distribution: USA and countries including Canada, Argentina, Australia, Bahrain, Belgium, Brazil, Chile, China, Columbia, Costa Rica, Czech Republic, Ecuador, Egypt, France, Germany, Greece,

Date initiated

2010-06-07

Date posted

2010-08-27

Date terminated

2012-07-12

Location

Raynham, MA