The Recall Desk
HighFDA (Devices)·Z-0532-2023·Announced 2022-12-21

FDA recalls Henry Schein bone marrow kit for defective seal

Henry Schein bone marrow kits may have incompletely sealed outer bags, compromising sterility. Affected units were distributed 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 medical device recall involving a potential sterility breach due to incomplete packaging seals. The hazard represents a risk of harm to patients, but without reported illnesses or injuries and given the theoretical nature of the risk, it meets the criteria for High severity.

Plain-English summary

The FDA is recalling Henry Schein bone marrow kits (Item No. 570-3092) manufactured by Stradis Medical, LLC dba Stradis Healthcare. The recall involves 581 units distributed throughout the US and Canada, with Serial/Lot Number 22231491193.

The kits underwent manufacturing conditions that resulted in outer bags being incompletely sealed. An incomplete seal may compromise the sterility of the kit, creating a risk of contamination.

Healthcare facilities and providers who received these kits should discontinue use and contact the manufacturer for instructions regarding return or replacement.

The recalled product

Product
HENRY SCHEIN, BONE MARROW KIT, Item No.570-3092
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Bone Marrow Biopsy Kit
Hazard
  • incomplete-seal
  • sterility-breach

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) H65857030921
  • UDI/DI (kit)M75257030920
  • Serial/Lot Numbers: 22231491193

Distribution

Distributed nationwide across the United States.

Related recalls

Same category