DVB KODAK DRYVIEW --- 35x43 cm --- 125 SHT --- REF 8723132 --- Made in U.S.A. by Carestream Health, Inc., 150 Verona St,

FDA device recall Z-0746-2012 · posted 2012-01-13 · Terminated

Recall details

Recalling firm

Carestream Health, Inc.

Reason for recall

Kodak DryView DVB Film is being recalled because it does not meet the specification for maximum density.

Action taken

Carestream Health Inc. sent an "URGENT PRODUCT REMOVAL" letter dated December 20, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to identify, segregate, and return any affected product to the firm. A Product Information Form was attached to the letter for customers to complete and return via fax to 541-831-7101. Contact Technical Support at 1-800-328-2910 for questions regarding this notice.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

IWZ

Quantity affected

24 cartridges

Distribution

Worldwide Distribution-USA (nationwide) including the states of Alabama, Florida, Georgia, and Tennessee and the country of Australia.

Date initiated

2011-12-20

Date posted

2012-01-13

Date terminated

2016-05-17

Location

Rochester, NY