Feb 7---Richard Wolf Medical recalls HULKA CLIPS

Manufacturer: -See Below-

Product: Medicals

Start Date: 2010-02-07  End Date: 2010-03-07

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; item 4986.90. Indicated for use for female sterilization (permanent contraception) by occluding the fallopian tubes. Recall # Z-0272-2010

CODE
Lot number: 1391, expiry date 02.2010

RECALLING FIRM/MANUFACTURER
Richard Wolf Medical Instruments, Corp., Vernon Hills, IL, by letters dated October 16, 2009. Firm initiated recall is ongoing.

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

VOLUME OF PRODUCT IN COMMERCE
150 cartons

DISTRIBUTION
Nationwide