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Class 2 Device Recall Trinity Sterile |
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Date Initiated by Firm |
February 23, 2021 |
Create Date |
April 21, 2021 |
Recall Status1 |
Terminated 3 on February 16, 2023 |
Recall Number |
Z-1468-2021 |
Recall Event ID |
87538 |
Product Classification |
Dressing change tray - Product Code OXQ
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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
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Code Information |
Lot Number: 600001 UDI: (01)00841767107942(17)2022-04- 30(10)600001 |
Recalling Firm/ Manufacturer |
Trinity Sterile, Inc. 201 Kiley Dr Salisbury MD 21801-2249
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For Additional Information Contact |
SAME 410-860-5123
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Manufacturer Reason for Recall |
Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility
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FDA Determined Cause 2 |
Under Investigation by 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 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. |
Quantity in Commerce |
2970 units |
Distribution |
US Nationwide distribution in the states of IA, IL, MN, MO, MS, NE, NE, NY, OH, OK, TX, VA. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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