Device Recall Richard Wolf Medical Instrument Corporation 의 리콜

Recall

68777

Class 2

Z-0037-2015

2014-07-09

2014-11-06

Terminated

United States

2017-04-24

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128639

Richard wolf medical instrument corporation is recalling hulka clip tubal occluding device lot 51000232. the devices are being recalled as a part of an investigation into a biocompatibility test discrepancy where the recalled lot (lot 51000232) passed final release testing, but the subsequent lot failed biocompatibility testing on a component that was also used to manufacture lot 51000232.

"Urgent: Medical Device Recall" letters dated July 9, 2014 were sent to all direct accounts (customers). The letters included instructions for customers to: 1) inspect their inventories for the recalled products; 2) contact Richard Wolf Medical Instruments at 800-323-9653 x 225 or 380 to notify Richard Wolf Medical Instruments if you have any devices in inventory; 3) review your records and report the number, if any, of Hulka Clips from lot 51000232 that were implanted in your patients on the Recall Response Form; 4) complete and return the Recall Response Form attached to the letter; and, 5) a RMA number will be provided to customers returning the recalled products and those customers will receive a credit. All returned product should be sent to the attention of Ms. Lisa Williams, Regulatory Specialist. Customers with questions can contact Richard Wolf Medical Instruments at 800-323-9653 x 225 or 380.