The Recall Desk
HighFDA (Devices)·Z-0361-2022·Announced 2021-12-22

Medline Venous Access Pack-LF Recalled for Expired Saline Component

Medline is recalling Venous Access Pack-LF Convenience Kits because the included saline solution component expired before the kit's labeled expiration date, creating a quality and safety issue.

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: This is a risk-of-harm product—expired pharmaceutical solutions cannot be assured as sterile and safe—where no injuries have been reported. The hazard is theoretical but significant enough to warrant recall of a medical device component.

Plain-English summary

Medline Industries Inc is recalling the Venous Access Pack-LF Convenience Kit (Model DYNJ36725B, Lot 19UBB149). These kits contain a NaCl (saline) 250 mL injection bag that expired in April 2020, while the kit itself has an expiration date of July 31, 2021. This means affected kits labeled as unexpired may contain an expired component.

The expired saline solution inside creates a quality and safety issue. Once a pharmaceutical solution expires, its sterility, safety, and effectiveness cannot be assured. Users may unknowingly use an expired component, potentially compromising patient safety during venous access procedures.

The recall affects kits with Lot 19UBB149 that were distributed nationwide in the United States.

If you have this product, do not use it. Contact Medline Industries Inc for guidance on product replacement or return.

The recalled product

Product
Venous Access Pack-LF Convenience Kit
Manufacturer
Medline Industries Inc
Hazard
  • expired-component
  • product-expiration-mismatch
  • quality-defect

Distribution

Distributed nationwide across the United States.