Recall Z-2330-2008 ยท JOJ Indicator, Physical/Chemical Sterilization Process
Propper Mfg Co Inc
Propper short gas-chex EO sterilization indicators, 250 strips per box, Reorder No. 269001, Propper Manufacturing Co., Inc., Long Island City, N.Y. 11101
| Date | Sep 20, 2008 (initiated Feb 7, 2008) |
| Status | Terminated |
| Reason | The firm discovered a production specification discrepancy that may cause the indicators to show an inaccurate result. |
| 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 t |
| Quantity | 1757 cases (7030 boxes) |
| Distribution | Nationwide and Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.