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Terminated

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

FDA Recall Z-1468-2021 · Posted None

Recalling FirmTrinity Sterile, Inc.
Recall StatusTerminated
Product CodeOXQ
Date Initiated2021-02-23
Date Terminated2023-02-16
Product Quantity2970 units

Reason for Recall

Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility

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 [email protected]. 3. Return the affected product. Once Trinity receives your completed Recall Acknowledgement form, a customer service representative will contact you with a Returned Goods Authorization (RGA) number covering your inventory and will provide instructions for the return of products. Questions, please contact Customer Service at 410-860-5123.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of IA, IL, MN, MO, MS, NE, NE, NY, OH, OK, TX, VA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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