Z-1828-2013Class II

Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor...

Name: Z-1828-2013 Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor...
Creator: Steritec Products Mfc. Co., Inc.
Published: 2013-06-10
License: https://open.fda.gov/license/

Steritec Products Mfg. Co., Inc. / initiated 2013-06-10 / Terminated / root cause: manufacturing process

FDA source

Steritec Products Mfc. Co., Inc. began a recall of Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR SteriTec Steam Biological... on 2013-06-10. FDA classified it as Class II and gives the reason as "Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the...". 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-1828-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-10
Posted: 2013-07-29
Terminated: 2013-12-19
Recalling firm: Steritec Products Mfg. Co., Inc.
Product: Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132C (270F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome
Product code: JOJ Indicator, Physical/Chemical Sterilization Process
Reason for recall: Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, SteriTec, sent all customers recall notifications via e-mail. The e-mail included a .pdf file of the recall notification letter entitled "URGENT: MEDICAL DEVICE RECALL" dated June 11, 2013. The letter described the product, problem and actions to be taken. The letter also informed customers of MesaLabs, "URGENT: MEDICAL DEVICE RECALL" letter dated June 7, 2013 to its customers. The customers were instructed to notify SteriTec products of receipt of this notification via email at: [email protected] or fax to: 303-660-4213 Attn: Director Regulatory Affairs; examine the lot number printed on the packaging components; place affected items in hold and do not sell or distribute these lots; record inventory of all items remaining in your warehouse and all items that have been distributed; advise SteriTec of the status of all inventory you received used or unused, if you have distributed the affected product to other locations within your healthcare system, notify them immediately of this recall, ask them to provide inventory status and proceed with destruction or return via instructions provided in letter-If you have shipping questions, please contact SteriTec directly at 303-660-4201, or email us at: [email protected], and also provide this notice to anyone in your facility that needs to be informed. Should you have any questions or concerns, please do not hesitate to contact Director of Regulatory Affairs and Quality Assurance or our offices at 303-660-4201. SteriTec's hours of operation are 7:30am Mountain Standard Time (MST) through 5:00pm MST.
Quantity in commerce: 3535 units
Distribution: Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.
Product codes and lots: Affected Biological Indicator Lot No.:130401

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1828-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1822-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-29
Z-1823-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-29
Z-1824-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-29
Z-1825-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-29
Z-1826-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-29
Z-1827-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-29
Z-1828-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-29
Z-1829-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-29

Product code JOJ

K001444Class IISteritec Steam Biological Test Pack with Instant Readout Integrator, Model Bi 103Steritec Products, Inc. / cleared 2000-05-15

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)