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U.S. Department of Health and Human Services

Class 2 Device Recall Trinity Sterile

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 Class 2 Device Recall Trinity Sterilesee related information
Date Initiated by FirmFebruary 23, 2021
Create DateApril 21, 2021
Recall Status1 Terminated 3 on February 16, 2023
Recall NumberZ-1468-2021
Recall Event ID 87538
Product Classification Dressing change tray - Product Code OXQ
ProductMidline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l
Code Information Lot Number: 600001 UDI: (01)00841767107942(17)2022-04- 30(10)600001
FEI Number 1000123297
Recalling Firm/
Manufacturer		 Trinity Sterile, Inc.
201 Kiley Dr
Salisbury MD 21801-2249
For Additional Information ContactSAME
410-860-5123
Manufacturer Reason
for Recall		Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility
FDA Determined
Cause 2		Under Investigation by firm
ActionTrinity 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 Commerce2970 units
DistributionUS Nationwide distribution in the states of IA, IL, MN, MO, MS, NE, NE, NY, OH, OK, TX, VA.
Total Product Life CycleTPLC Device Report
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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