Medical Action Industries Recalls Port-A-Cath Trays Due to Seal Defects
Medical Action Industries is recalling Port-A-Cath Trays because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.
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: The recall is classified as FDA Class II. The hazard involves compromised sterility of a medical device, which presents a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medical Action Industries, Inc. is recalling Port-A-Cath Trays (Model 58647B, Lot 187175) because some sterile kits may have incomplete seals. This defect might compromise the sterility of the kits, posing a risk of infection to patients.
The recall involves 474 cases (9,480 individual units) of the sterile, single-use, latex-free trays. These products were distributed in Arkansas, Arizona, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Minnesota, North Carolina, New York, Ohio, Tennessee, Texas, and Virginia. The expiration date for the affected lots is December 1, 2015.
Healthcare facilities and consumers should stop using these trays immediately. Users should check their inventory for the specific model and lot numbers listed above. If you have questions about this recall, contact Medical Action Industries, Inc. in Arden, North Carolina.
The recalled product
- Product
- Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
- Manufacturer
- Medical Action Industries Inc
- Category
- Medical Device — Surgical Trays
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)
- Model number: 58647B
- Lot number: 187175
- Exp. Date: 12/1/2015.
Distribution
Part of a larger recall action
This product is one of 8 recalled by Medical Action Industries Inc 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 8 products in this recall →Related recalls
Same manufacturer · Medical Action Industries Inc
See all →- HighMedical Action Industries Recalls Laparotomy Sponges Due to Sterility Concerns
FDA (Devices) · 2019-04-03
- HighMedical Action Industries Recalls Laparotomy Sponges Due to Sterility Compromise
FDA (Devices) · 2019-01-02
- HighMedical Action Industries Recalls Blue OR Towels Due to Sterility Concerns
FDA (Devices) · 2018-06-06
- ModerateMedical Action Industries Recalls Sterile Operating Room Towels Due to Lint
FDA (Devices) · 2017-05-24
- ModerateMedical Action Industries Recalls Blue OR Towels Due to Lint Presence
FDA (Devices) · 2017-05-24
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighMedical Action Industries Recalls Dialysis Change Tray Kits Due to Seal Defect
FDA (Devices) · 2026-08-12
- HighAvid Medical Recalls Custom Procedure Trays Due to Sterility Concerns
FDA (Devices) · 2020-03-25
- HighProcedural trays recalled for potential sterile packaging breach
FDA (Devices) · 2023-02-08
- HighAvid Medical Recalls Custom Procedure Trays Containing Non-Sterile Gowns
FDA (Devices) · 2020-03-25
- HighMedline Recalls Central Line Dressing Change Trays Due to Seal Defects
FDA (Devices) · 2020-09-30
- HighStradis Healthcare Recalls Sterile Port Access Tray Kits for Potential Sterility Breach
FDA (Devices) · 2023-01-18