Recall Z-0027-2007 ยท JOJ Indicator, Physical/Chemical Sterilization Process
3M Company / Medical Division
3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
| Date | Oct 11, 2006 (initiated Aug 9, 2006) |
| Status | Terminated |
| Reason | 3M Comply 1248 Gas Plasma Chemical Indicator Strips were manufactured with a material that may cause some of the indicators to show an inaccurate result if not read immediately after processing. |
| Root cause | Other |
| Action | The firm initiated a recall of the Comply 1248 product made with the discrepant material. Customer letters were sent on August 14, 2006. Letters notified customers of problem and instructed them to discontinue distribution or use of the product. Then to return all affected product to them. |
| Quantity | 6248 cases (4 boxes/case) |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013228 | 3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR Minnesota Mining and Mfg. Co., Jan 18, 2002 |