Z-0272-2010

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

Name: Z-0272-2010 Richard Wolf Hulka Clip; for single patient use only; a sterile tubal occluding device; 2 clips per procedure...
Creator: Richard Wolf Medical Instruments Corp.
Published: 2009-10-16
License: https://open.fda.gov/license/

Richard Wolf Medical Instruments Corp. / initiated 2009-10-16 / Terminated / root cause: packaging

FDA source

Richard Wolf Medical Instruments Corp. began a recall of Richard Wolf Hulka Clip; for single patient use only; a sterile tubal occluding device; 2 clips per procedure tray/pouch, 10 pouches per shipping carton... on 2009-10-16. The reason FDA records is "The sterile pouch seal may fail to remain intact during handling rendering the Hulka clip non-sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0272-2010
Status: Terminated
Initiated: 2009-10-16
Posted: 2009-11-17
Terminated: 2011-03-16
Recalling firm: Richard Wolf Medical Instruments Corp.
Product: Richard Wolf Hulka Clip; for single patient use only; a sterile tubal occluding device; 2 clips per procedure tray/pouch, 10 pouches per shipping carton; Richard Wolf Medical Instruments Corp., Vernon Hills, IL 60061; item 4986.90. Indicated for use for female sterilization (permanent contraception) by occluding the fallopian tubes
Product code: HGB Clip, Tubal Occlusion
Reason for recall: The sterile pouch seal may fail to remain intact during handling rendering the Hulka clip non-sterile.
Root cause tag: packaging
FDA root cause: Packaging
Action: 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.
Quantity in commerce: 150 cartons
Distribution: Nationwide
Product codes and lots: lot number 1391, expiry date 02.2010

Product code HGB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)