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
This recall has been terminated (originally issued February 23, 2021).
- Company
- Trinity Sterile, Inc.
- Recall Initiated
- February 23, 2021
- Terminated
- February 16, 2023
- Recall Number
- Z-1468-2021
- Quantity
- 2970 units
- Firm Location
- Salisbury, MD
- Official Source
- View on FDA website ↗
Reason for Recall
Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility
Distribution
US Nationwide distribution in the states of IA, IL, MN, MO, MS, NE, NE, NY, OH, OK, TX, VA.
Lot / Code Info
Lot Number: 600001 UDI: (01)00841767107942(17)2022-04- 30(10)600001
Root Cause
Under Investigation by firm
Action Taken
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 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.