The Recall Desk
HighFDA (Devices)·Z-0898-2022·Announced 2022-04-13

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.

What this means for you

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
Category
Medical Device — Injectable / IV Flush
Hazard
  • sterility-failure

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

Distributed nationwide across the United States.

Related recalls

Same category