Z-2330-2008

Propper short gas-chex EO sterilization indicators, 250 strips per box, Reorder No. 269001, Propper...

Name: Z-2330-2008 Propper short gas-chex EO sterilization indicators, 250 strips per box, Reorder No. 269001, Propper...
Creator: Propper Mfg Co Inc
Published: 2008-02-07
License: https://open.fda.gov/license/

Propper Mfg Co Inc / initiated 2008-02-07 / Terminated / root cause: manufacturing process

FDA source

Propper Mfg Co Inc began a recall of Propper short gas-chex EO sterilization indicators, 250 strips per box, Reorder No. 269001, Propper Manufacturing Co., Inc., Long Island City, N.Y. 11101 on 2008-02-07. The reason FDA records is "The firm discovered a production specification discrepancy that may cause the indicators to show an inaccurate result". 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-2330-2008
Status: Terminated
Initiated: 2008-02-07
Posted: 2008-09-20
Terminated: 2012-08-03
Recalling firm: Propper Mfg Co Inc
Product: Propper short gas-chex EO sterilization indicators, 250 strips per box, Reorder No. 269001, Propper Manufacturing Co., Inc., Long Island City, N.Y. 11101
Product code: JOJ Indicator, Physical/Chemical Sterilization Process
Reason for recall: The firm discovered a production specification discrepancy that may cause the indicators to show an inaccurate result.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: On 2/07/08, Propper Mfg. Co. sent URGENT: DEVICE RECALL letters (dated 2/07/08) to the direct consignees, informing them of the recall of the affected lots of Gas-Chex EO Indicator Strips. The letters also instructed them to: (1) check their inventory to determine if they have the recalled lots in stock; (2) discontinue use of the affected lots; (3) reprocess any unused packs that have been processed with the affected lots of Gas-Chex EO Indicator Strips with non-recalled lots or an alternative product from another supplier; (4) return the affected lots to Propper Manufacturing; (5) complete the enclosed form and return via fax to Propper Mfg. Propper Mfg. will send a postage-paid label and instruction for return of the product, and will ship replacement product as soon as possible. Propper also recommended that consignees review the risk associated with items that have been monitored with the subject chemical indicators although a sterilization cycle failure is unlikely due to equipment controls and other monitoring methods. For questions, please contact Propper at 1-800-832-4300 during regular business hours (9 am to 4:30 pm).
Quantity in commerce: 1757 cases (7030 boxes)
Distribution: Nationwide and Puerto Rico
Product codes and lots: Reorder No. 269001; Lots 6081, 6043, 6021, 7042, and 7013

Product code JOJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)