KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226

FDA device recall Z-0744-2013 · posted 2013-01-28 · Terminated

Recall details

Recalling firm

Carestream Health, Inc.

Reason for recall

Missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is missing but the expiration date is not missing. The Lot symbol is missing but the lot number is not missing. The Manufacturer symbol, name and address including country of origin are missing. All of the remaining symbols and information are on the case label. Missing information is only a

Action taken

Carestream sent an Urgent Customer Notification and Field Corrective Action Letters dated January 17, 2013 and response form to the domestic consignees via UPS Overnight Mail. The letter identified the affected product, problem and actions to be taken. In addition, the consignees were instructed to complete the response form and fax it back to Carestream to fax # 585-323-7643. For questions or concerns customers were instructed to contact the Carestream Customer Care Center in the U.S. at 1-800-933-8031.

Root cause

Process change control

Status

Terminated

Product code

IWZ

Quantity affected

101 cartons: Domestic - 95 cartons; Foreign - 6 cartons

Distribution

US Nationwide Distribution including the states of California, Florida, Texas, Illinois, Indiana, Maryland, Pennsylvania and Canada.

Date initiated

2013-01-17

Date posted

2013-01-28

Date terminated

2016-05-18

Location

Rochester, NY