Trinity Sterile, Inc. Recall 87538
Description: 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
Trinity Sterile, Inc. Recall 87538 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1468-2021 |
| Event ID | 87538 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of IA, IL, MN, MO, MS, NE, NE, NY, OH, OK, TX, VA. |
| Quantity | 2970 units |
| Recall Reason | Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility |
| Device Classification | 20210428 |
| Device Code Info | Lot Number: 600001 UDI: (01)00841767107942(17)2022-04- 30(10)600001 |
| Center Classification Date | 20210421 |
| Recall Initiation Date | 20210223 |
| Recalling Firm | Trinity Sterile, Inc. |
| Initial Notification | Letter |
| Similar To |