CLASS II Device recall · Reported 28 Apr 2021 · FDA Enforcement Report
Midline Catheter Dressing Change Kit with Statlock recalled
Trinity Sterile is recalling Midline Catheter Dressing Change Kit with Statlock, distributed nationwide in the US. The recall was initiated on 23 Feb 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1468-2021
- FDA event ID
- 87538
- Recalling firm
- Trinity Sterile, Salisbury, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Feb 2021
- FDA classified
- 21 Apr 2021
- Reported
- 28 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 23 Feb 2021 | Recall initiated by company | |
| 21 Apr 2021 | Classified by FDA | +57 days |
| 28 Apr 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution in the states of IA, IL, MN, MO, MS, NE, NE, NY, OH, OK, TX, VA.
Nationwide IowaIllinoisMinnesotaMissouriMississippiNebraskaNew YorkOhioOklahomaTexasVirginia
Questions about this recall
Why was it recalled?
Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility
Which lots are affected?
Lot Number: 600001 UDI: (01)00841767107942(17)2022-04- 30(10)600001
Where was it sold?
US Nationwide distribution in the states of IA, IL, MN, MO, MS, NE, NE, NY, OH, OK, TX, VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Trinity Sterile
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Tacy Medical, Inc Dressing Change Tray CS/20 recalled by Trinity Sterile | Trinity Sterile | Sterility | Nationwide |
| Device | CLASS II | Wolf-Pak Dressing Change Kit recalled by Trinity Sterile | Trinity Sterile | Sterility | Nationwide |
| Device | CLASS II | Wolf-Pak Dressing Change Kit recalled by Trinity Sterile | Trinity Sterile | Sterility | Nationwide |
| Device | CLASS II | IMed Products Dressing Change Kit with ChloraPrep & HaloGUARD recalled | Trinity Sterile | Sterility | Nationwide |
| Device | CLASS II | Wolf-Pak Premium Dressing Change Kit with GuardiVa & Statlock CS/30 recalled | Trinity Sterile | Sterility | Nationwide |
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| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
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