AccuGuide Injection Needles (Surface electrodes) The AccuGuide EMG Injection Needle, product 8263210, contains 5 individ
FDA device recall Z-0576-2007 · posted 2007-03-07 · Terminated
Recall details
- Recalling firm
- Medtronic Xomed, Inc.
- Reason for recall
- A labeling discrepancy was internally identified for the surface electrode component of REF 8263210 AccuGuide EMG Injection Needle, 30G X 25MM. The outside box label correctly indicates 'Content: 5 sterile Injection Needles and 10 non-sterile Surface electrodes'; however, the pouches for the 10 surface electrodes inside the box are incorrectly labeled as 'sterile'.
- Action taken
- Each consignee contacted via telephone 01/22/2007, and then sent a follow-up fax letter 02/02/2007, which explained the issue, and the options for dispositioning any product that they still had in stock. Since firm has determined that the risk of keeping and using these devices is negligible to no risk, as they are intended to be and typically used in a non-sterile manner, the firm is offering the consignees the option to keep their devices or have them replaced.
- Root cause
- Other
- Status
- Terminated
- Product code
- GZX
- Quantity affected
- 48 boxes
- Distribution
- Nationwide
- Date initiated
- 2007-01-22
- Date posted
- 2007-03-07
- Date terminated
- 2012-07-07
- Location
- Jacksonville, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCUGUIDE MUSCLE INJECTION MONITOR (K990793) | Medtronic Xomed | 1999-10-22 |