STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is used to provide traction and en

FDA device recall Z-1786-2013 · posted 2013-07-22 · Terminated

Recall details

Recalling firm

Steris Corporation

Reason for recall

A bearing used in the assembly of the Fine Traction Device did not perform successfully in pre-release reliability testing; a replacement bushing passed reliability testing and was substituted per a change order. The change order authorized use of the substitute bushing in assembly of the Fine Traction Accessory; however, inadvertently the new part was not implemented. During complaint evaluati

Action taken

STERIS Account Managers notified affected customers via onsite visits. All consignees were notified as of 5/29/2013. Customers were instructed to return affected product for a replacement unit.

Root cause

Component change control

Status

Terminated

Product code

HST

Quantity affected

16 units

Distribution

USA Nationwide Distribution in the states of CO, KY, LA, VA, and WI. The affected product was also distributed to Canada.

Date initiated

2013-05-20

Date posted

2013-07-22

Date terminated

2013-08-28

Location

Mentor, OH