Agency classClass IIOur severity:High FDA (Devices)·Z-0947-2023·Announced 2023-01-18

Stradis Healthcare Recalls Sterile Port Access Tray Kits for Potential Sterility Breach

Stradis Healthcare is recalling 600 units of Tacy Medical sterile port access trays due to potential pinhole leaks in the outer packaging that could compromise sterility.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 of a sterile medical device with a potential breach in sterility assurance. No illnesses or injuries have been reported. The hazard is theoretical—a potential defect that could compromise the sterile field—and per the rubric, recalls with no reported harm and theoretical hazards score at most 3 (High).

Plain-English summary

Stradis Healthcare is recalling 600 units of Tacy Medical, Inc PORT ACCESS TRAY (Sterile, QTY 20) due to a potential defect in the outer bag packaging. The outer bag may have pinhole leaks near the seal, which could compromise the sterility of the kit.

The affected units include Assembly Number TM8823-1, UDI-DI: M752TM882310, and Lot Number: 220110674. These units were distributed in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, and WA.

Healthcare facilities and users in the affected states who have received these kits should verify the lot number and assembly number. If units from this recall are identified, they should not be used. Contact Stradis Healthcare or the FDA if you have questions about whether your inventory is affected.

The recalled product

Product: Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.
Manufacturer: Stradis Healthcare
Category: Medical Device — Sterile surgical kit
Hazard: sterility-breach
contamination-risk
Affected units: 600

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)

Assembly Number TM8823-1
UDI-DI: M752TM882310
Lot Number: 220110674

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Part of a larger recall action

This product is one of 18 recalled by Stradis Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 18 products in this recall →

Same manufacturer · Stradis Healthcare

See all →

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HCT 6 CC Syringe Kits recalled for potential sterility breach from packaging leaks
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Fluid Filter Transfer Kit Recalled Over Potential Sterility Breaches
FDA (Devices) · 2023-01-18
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PHS Lacertaion Tray Sterile Kit Recall Due to Seal Leakage Risk
FDA (Devices) · 2023-01-18

Same hazard · sterility breach