3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Sy
FDA device recall Z-0027-2007 · posted 2006-10-11 · Terminated
Recall details
- Recalling firm
- 3M Company / Medical Division
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JOJ
- Quantity affected
- 6248 cases (4 boxes/case)
- Distribution
- Nationwide.
- Date initiated
- 2006-08-09
- Date posted
- 2006-10-11
- Date terminated
- 2007-05-25
- Location
- South St Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR (K013228) | Minnesota Mining and Mfg. Co. | 2002-01-18 |