Recall Z-1468-2021— Trinity Sterile, Inc.
Class II · Terminated
Class II FDA medical device recall by Trinity Sterile, Inc., initiated 2021-02-23, terminated 2023-02-16. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility.
- Recalling firm
- Trinity Sterile, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-02-23
- Terminated
- 2023-02-16
- Firm location
- Salisbury, MD, United States
Product 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
Reason for recall
Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility
Data sourced from openFDA. This site is unofficial and independent of the FDA.