Recall Z-0272-2010 ยท HGB Clip, Tubal Occlusion
Richard Wolf Medical Instruments Corp.
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
| Date | Nov 17, 2009 (initiated Oct 16, 2009) |
| Status | Terminated |
| Reason | The sterile pouch seal may fail to remain intact during handling rendering the Hulka clip non-sterile. |
| 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 |
| Quantity | 150 cartons |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.