The Recall Desk
HighFDA (Devices)·Z-0512-2023·Announced 2022-12-21

Medical and Surgical Procedure Trays Recalled for Incomplete Seal

Stradis Medical recalled Henry Schein Basic Pack medical and surgical procedure trays due to manufacturing defects causing incomplete outer bag seals that may compromise sterility. The affected kits were distributed nationwide in the US and Canada.

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 recall for a medical device with potential for patient harm due to sterility breaches. No illnesses or injuries have been reported. The incomplete seal poses a theoretical risk that meets the 'risk-of-harm products where injury has not yet been reported' criterion.

Plain-English summary

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

The recalled products underwent manufacturing conditions that may result in the outer bag being incompletely sealed. An incomplete seal may breach the sterility of the kit.

The affected product was distributed to customers in the United States and in Canada.

Customers who have received this product should stop using it and contact the manufacturer for instructions regarding the recall.

The recalled product

Product
HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot Numbers: 22242489505
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical/Medical Procedure Trays
Hazard
  • sterility-breach
  • seal-defect

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) H65857027181
  • UDI/DI (kit)M75257027180
  • Serial/Lot Numbers: 22242489582

Distribution

Distributed nationwide across the United States.

Related recalls

Same category