ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are
FDA device recall Z-1080-2015 · posted 2015-02-10 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- The product labeling does not specify the 5 year shelf life of the product.
- Action taken
- Urgent Medical Device Recall Notifications, dated January 2015, were sent to direct accounts that identified the product, problem, and actions to be taken. Customers were asked to discontinue use and return affected product.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- CAZ
- Quantity affected
- 63022
- Distribution
- Distribution US Nationwide, Canada and Mexico.
- Date initiated
- 2015-01-05
- Date posted
- 2015-02-10
- Date terminated
- 2018-07-17
- Location
- Reading, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER (K884552) | Arrow Intl., Inc. | 1989-03-14 |