Verify Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone Drive, Mentor, OH 44060 The Verif

FDA device recall Z-2417-2012 · posted 2012-09-20 · Terminated

Recall details

Recalling firm

Steris Corporation

Reason for recall

STERIS has learned that the Verify Bowie Dick Test Cards are not performing to product specifications. Specifically, test cards have resulted in false fail results when sterilizer performance is within acceptable ranges.

Action taken

Steris Corporation sent a Urgent Voluntary Recall Notice dated July 3, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to examine their inventory and compare the lot numbers printed on the box with the listed lots. If they have products from the affected lot numbers to contact STERIS Customer Service for account credit. After notifying STERIS of the amount of recalled product on hand they are to immediately destroy the product. Distributors are to also notify their customers of the recall. They are to send a copy of the Customer Recall Notice. They are to inventory their stock and notify STERIS of any remaining recalled product for replacement product. All recalled product should be destroyed. Please contact your STERIS Account Manager or STERIS Customer Service at 1-800-548-4873.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MLR

Quantity affected

629 cards

Distribution

Worldwide Distribution--USA (nationwide) including the states of AL, CA, CO, CT, FL, GA, IA, IN, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK,OR, PA, RI, SC, TX, UT, VA, WA, WI,

Date initiated

2012-07-03

Date posted

2012-09-20

Date terminated

2013-03-27

Location

Mentor, OH

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