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U.S. Department of Health and Human Services

Class 2 Device Recall GasChex sterilization indicators

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 Class 2 Recall
GasChex sterilization indicators
see related information
Date Posted September 20, 2008
Recall Status1 Open
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, New York 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 2
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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