Medical Action Industries Recalls Sterile Suture Sets Due to Seal Defects
Medical Action Industries is recalling sterile suture sets because incomplete seals may compromise sterility. The recall involves 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 in a medical device, which is a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Medical Action Industries, Inc. is recalling sterile, single-use suture sets (Model 58468B, Lot 187203) because some kits may have incomplete seals. This defect might compromise the sterility of the kits, posing a risk of infection to patients.
The recall involves a total of 474 cases (9,480 individual units). The affected 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.
Healthcare facilities and consumers should stop using these suture sets immediately. The products are identified by Model number 58468B, Lot number 187203, and an expiration date of 11/1/2016. Users should contact Medical Action Industries for further instructions on returning or disposing of the affected units.
The recalled product
- Product
- Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
- Manufacturer
- Medical Action Industries Inc
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: 58468B
- Lot number: 187203
- Exp. Date: 11/1/2016.
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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