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
Recall
- Recall Number
- Z-1468-2021
- Event Number
- 87538
- Firm
- Trinity Sterile, Inc.
- FEI Number
- 1000123297
- Product Code
- OXQ
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- February 23, 2021
- Terminated
- February 16, 2023
- Address
- 201 Kiley Dr, Salisbury, MD, 21801-2249
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
Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility
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.
US Nationwide distribution in the states of IA, IL, MN, MO, MS, NE, NE, NY, OH, OK, TX, VA.
2970 units