The Recall Desk
HighFDA (Devices)·Z-0544-2023·Announced 2022-12-21

Angioplasty Procedure Trays Recalled Due to Incomplete Bag Sealing

Stradis Healthcare angioplasty procedure trays may have incompletely sealed outer bags, risking sterility compromise. Affected units should not be used pending further instructions.

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 a risk-of-harm component (potential sterility breach) where no illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury are scored as High (3).

Plain-English summary

Stradis Medical, LLC dba Stradis Healthcare is recalling medical and surgical procedure trays and kits used in angioplasty procedures. The recall affects 100 units that underwent manufacturing conditions resulting in incomplete sealing of the outer packaging.

The incomplete sealing of the outer bag may result in a breach of the kit's sterility, potentially compromising the integrity of the medical device during use. Sterile surgical kits are essential for preventing contamination and infection risk during medical procedures. The affected trays and kits were distributed throughout the United States and Canada, with Lot/Serial Number 22237490509.

Healthcare facilities and medical professionals who have received these units should quarantine them immediately and discontinue their use in patient procedures. Contact Stradis Healthcare for instructions on product replacement or proper disposal. No illnesses or injuries have been reported in association with this recall.

The recalled product

Product
STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical / Angioplasty Trays
Hazard
  • incomplete-seal
  • sterility-breach
  • contamination-risk

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) M75268219371
  • UDI/DI (kit)M75268219370
  • Serial/Lot Numbers: 22237490509

Distribution

Distributed nationwide across the United States.

Related recalls

Same category