Z-2417-2012Class II

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

Name: Z-2417-2012 Verify Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone Drive, Mentor, OH...
Creator: Steris Corporation
Published: 2012-07-03
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2012-07-03 / Terminated / root cause: manufacturing process

FDA source

Steris Corporation began a recall of 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... on 2012-07-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2417-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-03
Posted: 2012-09-20
Terminated: 2013-03-27
Recalling firm: STERIS Corporation
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.
Product code: MLR Sterilizer, Chemical
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 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, WV and WY. and the country of Canada.
Product codes and lots: Model #S3098, Serial #"s: H20013, H20014, and H20016.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2417-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2417-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20

Product code MLR

K897045Class IIBowie-Dick Test Card Catalog Number 008018Edward Weck, Inc. / cleared 1990-02-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)