Class 2 Device Recall GasChex sterilization indicators

• Date Initiated by Firm: February 07, 2008
• Date Posted: September 20, 2008
• Recall Status: Terminated on August 03, 2012
• Recall Number: Z-2330-2008
• Recall Event ID: 48969
• Product Classification: Indicator, physical/chemical sterilization process - Product Code JOJ
• 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
• Code Information: Reorder No. 269001; Lots 6081, 6043, 6021, 7042, and 7013
• Recalling Firm/ Manufacturer: Propper Mfg Co Inc; 36-04 Skillman Avenue; Long Island City NY 11101-1730
• For Additional Information Contact: Andrew Sharavara; 718-392-6650
• Manufacturer Reason for Recall: The firm discovered a production specification discrepancy that may cause the indicators to show an inaccurate result.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.