The Recall Desk
HighFDA (Devices)·Z-1953-2014·Announced 2014-07-09

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.

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: 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.

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

Distributed in 15 states:

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 →