Medical Device Exchange -Suction Coagulator; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number E2505-10FR

FDA device recall Z-2225-2015 · posted 2015-07-24 · Terminated

Recall details

Recalling firm

EXP Pharmaceutical Services Corp

Reason for recall

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Action taken

EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014. A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.

Root cause

Other

Status

Terminated

Product code

GEI

Quantity affected

1

Distribution

Distributed in DC and the states of CO, CA, FL, TX, and AR.

Date initiated

2015-02-11

Date posted

2015-07-24

Date terminated

2015-12-30

Location

Fremont, CA