The Recall Desk
HighFDA (Devices)·Z-0529-2023·Announced 2022-12-21

Surgical Procedure Kits Recalled Due to Incomplete Outer Bag Sealing

Stradis Healthcare is recalling Henry Schein Custom PK 2 surgical procedure kits due to manufacturing defects that may result in incomplete outer bag sealing, potentially compromising sterility. The recall affects 27 units 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 a Class II medical device recall with no reported illnesses or injuries. The hazard is a potential sterility breach due to incomplete sealing—a risk-of-harm scenario where injury has not yet been reported, placing it in the High severity category per the rubric.

Plain-English summary

Stradis Medical, LLC (doing business as Stradis Healthcare) is recalling Henry Schein Custom PK 2 surgical procedure kits (Item No. 570-3072). The recall affects 27 units that were distributed nationwide in the United States and Canada.

The affected kits underwent certain manufacturing conditions that may have resulted in the outer bag being incompletely sealed. An incompletely sealed outer bag can result in a breach of the kit's sterility, which is essential for safe surgical use.

Healthcare providers who received these kits should discontinue use immediately. Contact the manufacturer for instructions on return or replacement of the affected units.

The recalled product

Product
HENRY SCHEIN, CUSTOM PK 2, Item No.570-3072
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical Kits / Procedure Trays
Hazard
  • sterility-assurance
  • incomplete-seal

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) H65857030721
  • UDI/DI (kit)M75257030720
  • Serial/Lot Numbers: 22241490953

Distribution

Distributed nationwide across the United States.

Related recalls

Same category