IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number 307, STERILE, Rx only --- Common/Usual Name: PTA and Esophageal Catheter --- Manufactured for: B. Braun Interventional Systems Inc., 824 Twelfth Avenue Bethlehem, PA18018 --- Manufactured by: NuMED, Inc. 2880 Main Street, Hopkinton, NY 12965 --- The Impact catheter is packaged in a straight sheath and then heat sealed in two Tyvek pouches. The inner pouch is the one that is deteriorating when exposed to the sunlight. The outer pouch retains its seal so the sterility is not compromised. --- 510 K931009 - Device Listing #D003206 and 510 K983373 - Device Listing # D003212, Class II device.
Recall
- Recall Number
- Z-0509-2010
- Event Number
- 53495
- Firm
- Numed Inc
- FEI Number
- 1318694
- Product Code
- LIT
- Status
- Terminated
- Root Cause
- Labeling design
- Initiated
- September 23, 2009
- Posted
- December 15, 2009
- Terminated
- May 23, 2012
- Address
- 2880 Main Street, Rt 11b, Hopkinton, NY, 12965
Description
IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number 307, STERILE, Rx only --- Common/Usual Name: PTA and Esophageal Catheter --- Manufactured for: B. Braun Interventional Systems Inc., 824 Twelfth Avenue Bethlehem, PA18018 --- Manufactured by: NuMED, Inc. 2880 Main Street, Hopkinton, NY 12965 --- The Impact catheter is packaged in a straight sheath and then heat sealed in two Tyvek pouches. The inner pouch is the one that is deteriorating when exposed to the sunlight. The outer pouch retains its seal so the sterility is not compromised. --- 510 K931009 - Device Listing #D003206 and 510 K983373 - Device Listing # D003212, Class II device.
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.
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
One distributor in Pennsylvania
7,367 units domestically