Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Number
FDA device recall Z-1947-2014 · posted 2014-06-30 · Terminated
Recall details
- Recalling firm
- Alcon Research, Ltd.
- Reason for recall
- Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle
- Action taken
- Alcon sent an Urgert Market Withdrawal letter dated May 14, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory to determine if they have any affected product, place the affected product into quarantine to ensure it is not used, return the attached Response Form via fax to 817-302-4337 or email market.action@Alcon.com. Customers with questions were instructed to call 1-800-862-5266.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- LRO
- Quantity affected
- 684 total (525 units in US)
- Distribution
- Nationwide Distribution including North Carolina and Maine
- Date initiated
- 2014-05-16
- Date posted
- 2014-06-30
- Date terminated
- 2014-12-09
- Location
- Fort Worth, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALCON SURGICAL PROCEDURE PACKS (K880961) | Alcon Laboratories | 1988-04-29 |