Medline Excelsior Medical Sterile Saline Flush Syringes Recalled for Sterility Failure
Medline Industries is recalling 7,800 Excelsior Medical 10mL Sterile Field Saline Flush syringes due to sterility failure of the exterior syringe surface, which may prevent the product from being safely used on a sterile field.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with documented sterility failure on a high-risk medical device (sterile injectable), but no illnesses or injuries reported. Per the rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
Medline Industries, LP is recalling 7,800 Excelsior Medical 10mL Sterile Field Saline Flush ZR syringes (Lot #3139133, expiring 11/01/2022). This product is a sterile 0.9% sodium chloride injection (saline) intended for intravenous flush use only.
The recalled syringes have sterility failure on the exterior surface, which compromises their ability to be laid on a sterile field. This defect may impact the product's intended use.
The affected products were distributed nationwide to Kentucky, Oklahoma, and Texas.
The recalled product
- Product
- 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.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 7,800
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #3139133
- Exp. 11/01/2022.
Distribution
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