Numed Inc 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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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

Distribution

As reported by FDA

IN, PA