The Recall Desk
HighFDA (Devices)·Z-0546-2023·Announced 2022-12-21

Stradis Healthcare Venous Access Pack Recalled for Potential Sterility Breach

Stradis Medical is recalling Venous Access Packs because the outer bag may be incompletely sealed, potentially compromising the sterility of the kit. 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: FDA Class II medical device recall with no reported illnesses or injuries. The hazard is theoretical—a potential sterility breach based on manufacturing defects that may result in incomplete sealing. Per the rubric, recalls with no reported illnesses and theoretical hazards score at most 3.

Plain-English summary

Stradis Medical, LLC dba Stradis Healthcare is recalling Venous Access Pack kits (Item No. 682-1993R1) with lot number 22235491208. The kits underwent manufacturing conditions that may result in the outer bag being incompletely sealed, which could compromise the sterility of the kit.

These medical and surgical procedure kits were distributed nationwide in the United States and in Canada. No illnesses or injuries have been reported related to this recall.

The recalled product

Product
STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1,
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical Kits
Hazard
  • sterility-breach
  • 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) M7526821993R11
  • UDI/DI (kit)M7526821993R10
  • Serial/Lot Numbers: 22235491208

Distribution

Distributed nationwide across the United States.

Related recalls

Same category