Recall Z-1468-2021 ยท OXQ Dressing Change Tray
Trinity Sterile, Inc.
Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l
| Date | Feb 23, 2021 |
| Status | Terminated |
| Reason | Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility |
| Root cause | Under Investigation by firm |
| Action | Trinity Sterile issued Urgent Medical Device recall letter on February 23, 2021 stating reason for recall, health risk and action to take: 1. Inspect your inventory for the affected product and lot number identified above. If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Notify Trinity. Please complete the enclosed Recall Acknowledgement form as soon as possible, indicating whether you do or do not have stock and fax it to 410-860-2913 or e-mail it to customerservice@trinitysterile.com. 3. Return the affected product. Once Trinity receives yo |
| Quantity | 2970 units |
| Distribution | US Nationwide distribution in the states of IA, IL, MN, MO, MS, NE, NE, NY, OH, OK, TX, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.