McCormick Medical Distribution PORT TRAY recalled for potential sterility breaches
Stradis Healthcare is recalling McCormick Medical Distribution PORT TRAY units due to potential pinhole leaks in the outer bag that could compromise sterility. Affected units were distributed nationwide.
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 of sterility from pinhole leaks in the outer bag seal. The hazard poses a risk of infection but no illnesses have been reported.
Plain-English summary
McCormick Medical Distribution PORT TRAY units are being recalled due to the potential for pinhole leaks near the seal of the outer bag. These leaks could result in a breach of the sterility of the kit.
The recall affects 250 units with Assembly Number MC-3535PT and UDI-DI M752MC3535PT1 (Lot Numbers: 220673037, 222096813). These trays were distributed nationwide in Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas, and Washington.
Healthcare facilities and patients who received these trays should verify they have not used units from the affected lots. Any concerns about product safety should be reported to the FDA or the manufacturer.
The recalled product
- Product
- McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.
- Manufacturer
- Stradis Healthcare
- Category
- Medical Device
- Affected units
- 250
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 (4)
- Assembly Number MC-3535PT
- UDI-DI: M752MC3535PT1
- Lot Numbers: 220673037
- 222096813
Distribution
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.
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