The Recall Desk
HighFDA (Devices)·Z-1110-2023·Announced 2023-02-22

Surgical angio port kits recalled for compromised sterile barrier

Medline is recalling 30 units of surgical angio port kits due to a perforated outer bag that prevents the external packaging from being sterile, creating a contamination risk during surgical use.

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 no reported illnesses or injuries. The hazard—compromised sterile barrier in surgical kits—represents a real risk of harm consistent with medical device contamination risks, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries is recalling 30 units of MEDLINE ANGIO PORT KIT W/HIGH GRADE IN (Reorder Number DYNDC2691, Lot #22HMG394) distributed nationwide.

The recall was initiated due to perforations in the outer bag of the surgical convenience kit. These perforations prevent the external surface of the kit packaging from maintaining sterility. Only the contents inside the kit wrapping are guaranteed to be sterile, compromising the protective barrier essential for surgical use.

Healthcare facilities and healthcare providers who have received this kit should cease use immediately. The non-sterile external surface poses a contamination risk if the kit is used in surgical procedures.

If you have this product, contact Medline Industries for instructions on return or destruction of the affected units.

The recalled product

Product
Surgical convenience kits labeled as: MEDLINE ANGIO PORT KIT W/HIGH GRADE IN, Reorder Number DYNDC2691
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • sterility-compromise
  • contamination

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)

  • GTIN 40193489343800
  • Lot # 22HMG394

Distribution

Distributed nationwide across the United States.