Verify SixCess Indicator Strips, Model #: PCC005, PCC006, PCC007, PCC008, PCC031, PCC033, PCC034, PCC037 & PCC038, Mfr.

FDA device recall Z-3045-2011 · posted 2011-08-22 · Terminated

Recall details

Recalling firm

Steris Corporation

Reason for recall

During an inspection the firm was notified that language contained in labeling and promotional literature directs Customers that the products can be used to replace biological indicators and/or release loads containing implants.

Action taken

STERIS sent a Customer Notification letter dated March 16, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review and follow the Challenge Packs' revised instructions for use enclosed as Attachment A (270-4) and Attachment B (275F 3). For any questions regarding this recall customers were instructed to contact their STERIS Account Manager or call 440-392-7421.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

JOJ

Quantity affected

2,500 (one per customer)

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Lebanon and Qatar.

Date initiated

2011-03-16

Date posted

2011-08-22

Date terminated

2013-03-19

Location

Mentor, OH