Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in th

FDA device recall Z-0029-2014 · posted 2013-10-18 · Terminated

Recall details

Recalling firm

OPTI Medical Systems, Inc

Reason for recall

OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could perfect the performance of one or more parameters as the product ages. Also a Customer complaint from a distributor reported that a customer was getting QC failures.

Action taken

The firm, OPTIMedical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated August 9, 2013 via email and fax to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of the product; return any unused product to OPTI Medical System; distributors outside the U.S. may destroy unused product and certify the instructions on the enclosed Recall Response Card; contact your distributor or OPTI Medical System Technical Support at 1-800-490-6784 or technicalsupport@optimedical.com to obtain authorization number and shipping instructions; and complete and return the Recall Response Card to technical support via fax to 1-770-510-4447; mail to: OPTI Medical Technical Support, OPTI Medical Systems, Inc., 235 Hembree Park Drive, Roswell, GA 30076 or email: technicalsupport@optimedical.com Please contact OPTI Medical Systems, Technical Support department at 1-800-490-6784 if you have questions related to this notice.

Root cause

Error in labeling

Status

Terminated

Product code

JJE

Quantity affected

361 boxes of 25 cassettes each

Distribution

Worldwide distribution: US (nationwide) including states of: CA, MA, MN, and VA; and countries of: China, Guatemala, India, Iraq, South Korea, and Untied Arab Emirates.

Date initiated

2013-08-09

Date posted

2013-10-18

Date terminated

2013-12-12

Location

Roswell, GA

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