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 |
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