The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1950-2014·Announced 2014-07-09

Medical Action Industries Recalls Sterile Laceration Trays Due to Seal Defects

Medical Action Industries is recalling sterile laceration 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, which poses a risk of infection (risk-of-harm product), but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.

Plain-English summary

Medical Action Industries, Inc. is recalling sterile, single-use laceration trays due to a defect in the packaging seals. The company reports that some of the sterile kits may have incomplete seals, which might compromise the sterility of the kits. The affected products are latex-free and are sold in cases of 20.

The recall involves a total of 474 cases (9,480 individual trays) across four specific model numbers: 68350, 58168, 68297B, and 72851B. Specific lot numbers and expiration dates are listed in the agency's structured data. The products were distributed in the states of Arkansas, Arizona, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Minnesota, North Carolina, New York, Ohio, Tennessee, Texas, and Virginia.

This is a Class II recall, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Consumers and healthcare facilities should stop using the affected trays and contact Medical Action Industries for instructions on return or replacement.

The recalled product

Product
Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC.
Manufacturer
Medical Action Industries Inc
Category
Medical Device — Surgical Supplies
Hazard

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 (13)

  • Model number: 68350
  • Lot numbers: 187146
  • 187341
  • 187150 & 187148
  • Exp. Date: 12/01/2016
  • Model number: 58168
  • Lot number: 187212
  • Exp. Date: 11/1/2016
  • Model number: 68297B
  • Lot number: 187196
  • Exp. Date: 12/1/2016 and Model number: 72851B
  • Lot number: 187208
  • Exp. Date: 12/1/2018.

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 →

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