iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) iovera Smart Tips are indiv
FDA device recall Z-2201-2015 · posted 2015-07-22 · Terminated
Recall details
- Recalling firm
- Myoscience Inc
- Reason for recall
- The expiration date on the outer box label and the pouch label for the iovera Smart Tip product is incorrect. Instead of indicating the correct expiration or 2015-12. the labels were incorrectly labeled 2016-05.
- Action taken
- Myoscience sent an Urgent Medical Device Correction letters dated July 1, 2015 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are requested to quarantine any affected product at their site. Myoscience will make arrangements to either correct the incorrect expiation date label or remove the product and replace it with correctly labeled product immediately. Question or concerns may be directed to Customers Service at 510-933-1500.
- Root cause
- Incorrect or no expiration date
- Status
- Terminated
- Product code
- GXH
- Quantity affected
- 12 boxes - 3 boxes of 10 count and 9 boxes of 5 count.
- Distribution
- US Nationwide Distribution in the states of TX, NY, MD, CO and CA.
- Date initiated
- 2015-07-01
- Date posted
- 2015-07-22
- Date terminated
- 2015-09-08
- Location
- Fremont, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Myoscience iovera system (K142866) | Myoscience, Inc. | 2015-01-21 |