Medical Action Industries Recalls Max Barrier Kits Due to Seal Defects
Medical Action Industries is recalling Max Barrier 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 (incomplete seals) could compromise sterility, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Medical Action Industries, Inc. is recalling the Max Barrier Kit, Sterile Single Use, Latex Free, 20/case. The recall is due to a defect where some of the sterile kits may have incomplete seals, which might compromise the sterility of the kits.
The recall involves 474 cases (9,480 individual kits) of Model number 70828, Lot number 187176, with an expiration date of 1/1/2016. These products were distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.
Consumers and healthcare facilities should stop using the affected kits and contact Medical Action Industries, Inc. for further instructions or a refund.
The recalled product
- Product
- Max Barrier Kit, 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: 70828
- Lot number: 187176
- Exp. Date: 1/1/2016.
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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