CLASS II Device recall · Reported 13 Apr 2022 · FDA Enforcement Report
Excelsior Medical Sterile Field Saline Flush ZR recalled
Medline Industries LP - Northfield is recalling Excelsior Medical Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, distributed nationwide in the US. The recall was initiated on 4 Mar 2022 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-0898-2022
- FDA event ID
- 89795
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Mar 2022
- FDA classified
- 8 Apr 2022
- Reported
- 13 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Syringes & Needles
Timeline
| 4 Mar 2022 | Recall initiated by company | |
| 8 Apr 2022 | Classified by FDA | +35 days |
| 13 Apr 2022 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.
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
Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.
Where it was distributed
US Nationwide Distribution was made to KY, OK, and TX. There was no foreign/government/military distribution.
Questions about this recall
Why was it recalled?
Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.
Which lots are affected?
Lot #3139133, Exp. 11/01/2022.
Where was it sold?
US Nationwide Distribution was made to KY, OK, and TX. There was no foreign/government/military distribution.
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.
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