Richard Wolf Hulka Clip; for single patient use only; a sterile tubal occluding device; 2 clips per procedure tray/pouch

FDA device recall Z-0272-2010 · posted 2009-11-17 · Terminated

Recall details

Recalling firm

Richard Wolf Medical Instruments Corp.

Reason for recall

The sterile pouch seal may fail to remain intact during handling rendering the Hulka clip non-sterile.

Action taken

Richard Wolfe sent recall letters dated October 16, 2009 to the direct accounts via certified mail on the same date. The accounts were informed that the lot of Hulka clips did not meet their sterile seal burst test requirements, and that the sterile seal may fail to remain intact during handling, resulting in the clips becoming contaminated or non-sterile. They were instructed to inspect their inventory for the affected lot, quarantine any product found and call Richard Wolf at 800-323-9653, ext 225 or 380 to arrange for the return of the affected product for replacement. The accounts were also requested to complete and return the enclosed response form to Richard Wolf, even if they do not have any of the affected lot in stock.

Root cause

Packaging

Status

Terminated

Product code

HGB

Quantity affected

150 cartons

Distribution

Nationwide

Date initiated

2009-10-16

Date posted

2009-11-17

Date terminated

2011-03-16

Location

Vernon Hills, IL