Medical Action Industries Recalls Sterile Laceration Kits Due to Seal Defects
Medical Action Industries is recalling sterile laceration and suture removal kits 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 involves a risk-of-harm product (sterile medical device) where the defect could compromise sterility, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Medical Action Industries, Inc. is recalling sterile, single-use laceration and suture removal kits. The recall is due to a potential defect where some kits may have incomplete seals, which could compromise the sterility of the contents.
The affected product is identified by Model number 72347, Lot number 187172, and an expiration date of 9/1/2015. A total of 474 cases (9,480 individual kits) were involved in the recall. These kits were distributed in the states of Arkansas, Arizona, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Minnesota, North Carolina, New York, Ohio, Tennessee, Texas, and Virginia.
Consumers and healthcare facilities should stop using the affected kits and contact Medical Action Industries for instructions on how to return or dispose of the product.
The recalled product
- Product
- Laceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
- Manufacturer
- Medical Action Industries Inc
- Category
- Medical Device — Surgical Kits
- 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 (3)
- Model number: 72347
- Lot number: 187172
- Exp. Date: 9/1/2015.
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.
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