IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number 307, STERILE, Rx only --- Common/U
FDA device recall Z-0509-2010 · posted 2009-12-15 · Terminated
Recall details
- Recalling firm
- Numed Inc
- Reason for recall
- The firm received a complaint from the sole direct account that while performing an inventory review it was observed that the packaging of the IMPACT catheter was cracked and deteriorating. The product was still in its packaging and never used. The customer referred to it as looking like "paint crackle." The risk is that for continued sterility to be assured, the packaging must remain intact.
- Action taken
- An informal e-mail was sent to B. Braun to give them notice not to distribute any Impact devices until further notice. This was followed up by a formal URGENT MEDICAL DEVICE RECALL letter (dated 9/24/09) to the sole consignee. The products are to be returned to the manufacturer, including any products further distributed. Customer questions should be directed to the recall contact (replace " AT " with @) nlaflesh ATnumedusa.com
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- LIT
- Quantity affected
- 7,367 units domestically
- Distribution
- One distributor in Pennsylvania
- Date initiated
- 2009-09-23
- Date posted
- 2009-12-15
- Date terminated
- 2012-05-23
- Location
- Hopkinton, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMPACT BALLOON DILATION CATHETER (K983373) | B. Braun/Mcgaw | 1999-06-22 |
| TYSHAK PERIPHERAL BALLOON DILATION CATHETER (K931009) | NuMED, Inc. | 1993-12-21 |