—#112673

Product

Verify Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone Drive, Mentor, OH 44060 The Verify Bowie-Dick Test Card consists of a card printed on one side with bars of chemical indicator ink. On the opposite side of the card, space is provided for critical cycle information to be recorded. The card is laminated inside a thin clear plastic enclosure. The enclosure has two holes in it to allow air removal and steam penetration. The preassembled test is used to evaluate the effectiveness of air removal from the sterilizer chamber during prevacuum pulse steam sterilizer cycle. Following a prevacuum cycle, the chemical bars of the Bowie-Dick Test card uniformly darken indicating that residual air has been sufficiently removed to allow complete steam penetration into the test card. If air is trapped in the card during the exposure phase of the cycle, the color change of the bars will be incomplete or uneven. Thus the card can provide an immediate indication of inadequate removal of air during a cycle. The Bowie-Dick Type test is performed in an empty chamber each day the sterilizer is to be used, usually before the first sterilization cycle.

FDA product code: MLR — Sterilizer, Chemical
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K897045
Affected lot / code info: Model #S3098, Serial #"s: H20013, H20014, and H20016.

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

Distribution pattern: 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, WV and WY. and the country of Canada.

Timeline

Recall initiated: 2012-07-03
Posted by FDA: 2012-09-20
Terminated: 2013-03-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #112673. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.