Z-1468-2021Class II

Midline Catheter Dressing Change Kit with Statlock -

Name: Z-1468-2021 Midline Catheter Dressing Change Kit with Statlock -
Creator: Trinity Sterile, Inc.
Published: 2021-02-23
License: https://open.fda.gov/license/

Trinity Sterile, Inc. / initiated 2021-02-23 / Terminated / root cause: sterility

FDA source

Trinity Sterile, Inc. began a recall of Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter... on 2021-02-23. FDA classified it as Class II and gives the reason as "Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1468-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-23
Posted: 2021-04-21
Terminated: 2023-02-16
Recalling firm: Trinity Sterile, Inc.
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
Product code: OXQ Dressing Change Tray
Reason for recall: Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility
Root cause tag: sterility
FDA root cause: 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 [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.
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.
Product codes and lots: Lot Number: 600001 UDI: (01)00841767107942(17)2022-04- 30(10)600001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1468-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1468-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21

Product code OXQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)