Recall Z-2393-2008 ยท GBM Catheter, Urethral
Apogee Medical, Inc
Apogee Intermittent Catheter with Coude tip, 12 Fr 16", Catalog/Ref No. 1036, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder.
| Date | Sep 21, 2008 (initiated Jul 17, 2008) |
| Status | Terminated |
| Reason | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised. |
| Root cause | Packaging process control |
| Action | Distributors and Retailers that have received any of the Catalog Numbers listed in the letter titled URGENT MEDICAL DEVICE RECALL were notified on/about July 17, 2008. Recipients of the letter are being requested to review their inventory and return any of the applicable Catalog Items from the specific lot numbers listed in the recall letter. Distributors are being instructed to notify their customers and inform them of the recall with a copy of the recall letter. Their notification should instruct their customers to return the recalled product to them so that they could return the product to |
| Quantity | 2700 pcs |
| Distribution | U.S. Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992137 | UROLOGICAL CATHETER Apogee, Inc., Sep 3, 1999 |