The Recall Desk
HighFDA (Devices)·Z-0531-2023·Announced 2022-12-21

Medical Surgical Trays and Kits Recalled for Incomplete Outer Bag Sealing

Henry Schein Blue Tail Custom Pack surgical procedure trays are being recalled because manufacturing issues may have caused incomplete sealing of the outer bag, potentially compromising sterility.

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 involving potential sterility breach in surgical medical devices. Although the hazard is theoretical with no reported illnesses or injuries, this qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Stradis Medical, LLC dba Stradis Healthcare is recalling the HENRY SCHEIN Blue Tail Custom Pack (Item No. 570-3091), a medical and surgical procedure tray and kit. Manufacturing conditions may have resulted in incomplete sealing of the outer bag.

An incompletely sealed outer bag may compromise the sterility of the kit, which could affect the safety of the product when used in medical procedures. No illnesses or injuries have been reported.

The recall involves 72 units with Lot Number 22258490762, distributed nationwide in the United States and in Canada.

The recalled product

Product
HENRY SCHEIN, Blue Tail Custom Pack, Item No.570-3091,
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical Trays / Procedure Kits
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) H65857030911
  • UDI/DI (kit)M75257030910
  • Serial/Lot Numbers: 22258490762

Distribution

Distributed nationwide across the United States.

Related recalls

Same category