Recall Z-0363-2017 ยท LJE Catheter, Nephrostomy
C.R. Bard, Inc.
X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081 The product is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm) balloon mounted on the distal tip. It has a radiopaque tip and radiopaque marker beneath the balloon. It is recommended for use in the dilation of the nephrostomy tact and for placement of the working sheath.
| Date | Oct 12, 2016 |
| Status | Terminated |
| Reason | Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr. |
| Root cause | Unknown/Undetermined by firm |
| Action | The firm, Bard Medical, sent an "URGENT: MEDICAL DEVICE PRODUCT RECALL" letter dated 10/13/2016 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine product subject to recall; do not use or further distribute any affected product; complete and return the attached Recall & Effectiveness Check Form regardless of whether or not you have any of the affect product by fax to 1-770-784-6469 or email a scanned copy to BMD.FieldAction@crbard.com by October 24, 2016, and if you have furth |
| Quantity | 192 units |
| Distribution | Worldwide distribution: US distribution to: CA, KS, MO, NY, VA, WA, and to countries of: China, Italy, Sweden and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063632 | X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER C.R. Bard, Inc., Jan 5, 2007 |