Recall Z-0559-06 ยท LRC Instrument, Ent Manual Surgical
Acclarent Inc
Acclarent brand Relieva Sinus Inflation Device Kit; Model BID30; The kit contains 1 inflation device, 1-10'' extension tube, 1-20cc syringe, 3-way stop-cock; Manufactured for Acclarent, Inc., 1525-B O''Brien Dr., Menlo Park, CA 94025
| Date | Feb 24, 2006 (initiated Jan 20, 2006) |
| Status | Terminated |
| Reason | Device sterility may be compromised as evidenced by a loss of package integrity. |
| Root cause | Other |
| Action | On 1/20/06 the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned. |
| Quantity | 149 units |
| Distribution | The product was released for distribution to 15 consignees in US. The recall was appropriately extended to the consumer/user level; i.e., the direct accounts (users) who received the recalled product. There is one Veterans Affairs account: Dept. of Veterans Affairs Medical Center PA, 1 215 82 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.