Medical Action Industries Recalls Laceration Kits Due to Seal Defects
Medical Action Industries is recalling sterile laceration 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 (compromised sterility) where injury has not yet been reported, fitting the High severity criteria for theoretical risk without confirmed illness.
Plain-English summary
Medical Action Industries, Inc. is recalling sterile laceration kits (Model 68718, Lot 187198) because some units may have incomplete seals. This defect might compromise the sterility of the kits, posing a risk of infection if used.
The recall involves 474 cases (9,480 individual kits) that were distributed in Arkansas, Arizona, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Minnesota, North Carolina, New York, Ohio, Tennessee, Texas, and Virginia. The affected products have an expiration date of 12/1/2016.
Healthcare facilities and consumers should stop using these kits and contact Medical Action Industries for instructions on return or replacement. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
- Manufacturer
- Medical Action Industries Inc
- Category
- Medical Device — Surgical Kits
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: 68718
- Lot number: 187198
- Exp. Date: 12/1/2016.
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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