The Recall Desk
HighFDA (Devices)·Z-1117-2023·Announced 2023-02-22

Surgical convenience kits recalled due to sterile packaging failure

Medline Industries is recalling 138 surgical convenience kits nationwide because the outer packaging does not maintain sterility. Only the contents inside the kit wrapper are sterile, creating a contamination risk.

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 an FDA Class II medical device recall for a potential sterility breach without reported illnesses or injuries. The hazard is theoretical—loss of the sterility barrier—placing it in the 'risk-of-harm products where injury has not yet been reported' category per the severity rubric.

Plain-English summary

Medline Industries, LP is recalling 138 units of the CENTURION MEDICAL PRODUCTS L & D TRAY surgical convenience kits (Reorder Number MNS9065, Lot # 22HMF916). The recall affects units distributed nationwide.

The recall was initiated because the perforated outer bag does not provide a sterility barrier. As a result, only the contents inside the kit wrapping are sterile, while the exterior packaging is not. This defect could allow contamination of the surgical kit.

Healthcare facilities and providers should stop using affected kits immediately. To identify affected units, check for the lot number 22HMF916. Consumers should contact Medline Industries for a replacement or return instructions.

The recalled product

Product
Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS L & D TRAY, Reorder Number MNS9065
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • sterility-issue
  • packaging-defect
  • contamination-risk

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 40653160274385
  • Lot # 22HMF916

Distribution

Distributed nationwide across the United States.