The Recall Desk
HighFDA (Devices)·Z-0551-2023·Announced 2022-12-21

Medical Surgical Trays: Incomplete Outer Bag Sealing May Breach Sterility

Stradis Medical is recalling surgical procedure trays due to incomplete sealing of the outer bag, which may compromise the sterility of the kit.

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 of surgical medical devices with sterility breach risk. Although no illnesses or injuries have been reported, the potential for serious harm from compromised sterility in surgical applications qualifies this as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Stradis Medical, LLC dba Stradis Healthcare is recalling medical and surgical procedure trays and kits due to a manufacturing defect.

During manufacturing, the outer bag may become incompletely sealed. An incomplete seal may result in a breach of the sterility of the kit, which could compromise the safety of the product for surgical use.

The recalled product (Item No. 682-577, Lot 22230490618) was distributed nationwide in the United States and Canada. The recall affects 15 units.

Consumers who have received this product should not use it and should contact the manufacturer for instructions on returning or replacing the affected kits.

The recalled product

Product
STRADIS HEALTHCARE, Vein, Item No.682-577,
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical Kits
Hazard
  • sterile-breach
  • incomplete-sealing

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 (3)

  • UDI/DI (case) M7526825771
  • UDI/DI (kit)M7526585770
  • Serial/Lot Numbers: 22230490618

Distribution

Distributed nationwide across the United States.

Related recalls

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