lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA,

FDA device recall Z-1517-2013 · posted 2013-06-07 · Terminated

Recall details

Recalling firm

Invatec Llc

Reason for recall

Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications for use was modified.

Action taken

Invatec sent an Urgent - Device Field Action letter dated March 4, 2009, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were required to return a confirmation form, acknowledging the action taken, and identifying affected units in their inventory for return of the product for replacement. The firm indicated that this recall was fully executed in 2009, and this 806 captures the events that took place at that time. For questions regarding this recall call 707-566-1143.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

DXE

Quantity affected

177 units

Distribution

Nationwide Distribution

Date initiated

2009-03-04

Date posted

2013-06-07

Date terminated

2013-06-10

Location

Bethlehem, PA

Related 510(k) clearances