Alcon Custom Pak
FDA device recall Z-0053-2018 · posted 2017-08-25 · Terminated
Recall details
- Recalling firm
- Alcon Research, LTD.
- Reason for recall
- Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ray detectable sponges. The one product referenced in the supplier recall notification, is used within Alcon Custom Paks.
- Action taken
- The medical user was sent a customer recall notification letter on 8/7/17. The medical user is requested to return the unused, affected Custom Paks to Alcon. Upon receipt and verification, Alcon will destroy the affected sponges in a controlled manner via physical destruction.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LRO
- Quantity affected
- 33 units
- Distribution
- States in the US - WI, NY, MO
- Date initiated
- 2017-08-08
- Date posted
- 2017-08-25
- Date terminated
- 2019-08-05
- Location
- Houston, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALCON SURGICAL PROCEDURE PACKS (K880961) | Alcon Laboratories | 1988-04-29 |