Recall Z-0814-2014 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Bard Access Systems
MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Product Code 0603880. Product Usage: The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Systems finished goods as Attachable or Preconnected catheters in BardPort Implanted Port Kits These products are used for patient therapies requiring repeated access to the vascular system. They are
| Date | Jan 23, 2014 (initiated Dec 6, 2013) |
| Status | Terminated |
| Reason | Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr instead of 6.6 Fr as stated in the labeling for the device. |
| Root cause | Process control |
| Action | BARD sent an Urgent Product Recall letter dated October 2013 to affected customers via certified letter. The letter identified the affected product, problem and actions to be taken. Customers were asked to check all inventory locations, remove and return any unused affected prodcut to Bard Access Systems through return goods authorization number RAP80498 for a credit or replacement, and to complete the Reply Form and Inventory Reconcilation Form. For questions contact BAS Customer Service at 1-800-290-1689. |
| Quantity | 1358 |
| Distribution | Worldwide Distribution - US nationwide, Belgium, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.