Steris QFC1728 and QFC1729 Quick Connects used in connections and processing endoscopes. The QFC1728 is used to process

FDA device recall Z-0967-2007 · posted 2007-06-21 · Terminated

Recall details

Recalling firm

Steris Corp

Reason for recall

The center insert of the adaptor #6 restrictor could become loose and/or come out of the housing and may affect the sterilization process of the attached endoscope

Action taken

On February 22, 2007, customers were contacted by phone and were notified by recall letter dated February 23, 2007. The recall notifications indicate that Steris Account managers will visit each consignee and replace affect product.

Root cause

Process control

Status

Terminated

Product code

MED

Quantity affected

146

Distribution

Worldwide-The product was distributed to USA domestic consignees located in MT, CA, NJ, IA, MA, WY, SC, MO, SC, TN, ID, MT, CO, PA, NV, and TX, and to foreign consignees located in Great Britian and Q

Date initiated

2007-02-23

Date posted

2007-06-21

Date terminated

2012-03-01

Location

Mentor, OH