LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation Sy

FDA device recall Z-0093-2017 · posted 2016-10-17 · Terminated

Recall details

Recalling firm

Tearscience, Inc

Reason for recall

Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator.

Action taken

The firm, TearScience, sent a "Medical Device Recall" letter dated September 9, 2016 to its consignees/customers on 9/13/2016. The letter described the product, problem and actions to be taken. The customers were instructed to complete and return the enclosed Acknowledgement and Receipt form by fax to (919) 882-9603, email to: Customerservice@tearscience.com or mail to TearScience, ATTN: CUSTOMER SERVICE RCL001, 5151 McCrimmon Parkway, Ste 250, Morrisville, NC 27560; to discontinue use of the product; to remove all a product with lot #201615220020 from your inventory; and call TearScience Customer Service at 919-459-4891 to return the product for above mentioned lot# and request new product for replacement. For any questions regarding this letter, please call (919) 459-4891 Monday through Friday, 8:30AM to 5:30PM, Easter Time.

Root cause

Device Design

Status

Terminated

Product code

ORZ

Quantity affected

1,200 Activators (120 boxes of 10 units)

Distribution

US Distribution including states of: AK, AR, CA, CO, FL, GA, ID, IL, IN, LA, MD, MA, MN, MO, NV, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA , WA, WI and Puerto Rico.

Date initiated

2016-09-13

Date posted

2016-10-17

Date terminated

2017-02-09

Location

Morrisville, NC

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