Acclarent brand Relieva Sinus Inflation Device Kit; Model BID30; The kit contains 1 inflation device, 1-10'' extension t
FDA device recall Z-0559-06 · posted 2006-02-24 · Terminated
Recall details
- Recalling firm
- Acclarent Inc
- Reason for recall
- Device sterility may be compromised as evidenced by a loss of package integrity.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LRC
- Quantity affected
- 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.
- Date initiated
- 2006-01-20
- Date posted
- 2006-02-24
- Date terminated
- 2006-05-11
- Location
- Menlo Park, CA
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