Medical Action Industries Recalls Safety Laceration Kits Due to Seal Defects
Medical Action Industries is recalling Safety 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.
Plain-English summary
Medical Action Industries, Inc. is recalling Safety Laceration Kits, Sterile Single Use, Latex Free, 20/case. The recall involves 474 cases (9,480 individual kits) of Model number 59108B, Lot number 187210, with an expiration date of 2/1/2017.
The recall was initiated because some of the sterile kits may have incomplete seals, which might compromise the sterility of the kits. The affected 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 check their inventory for the specific model and lot numbers listed above. If the product is found, it should be removed from use and returned to the supplier or the manufacturer for further instructions.
The recalled product
- Product
- Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
- Manufacturer
- Medical Action Industries Inc
- 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: 59108B
- Lot number: 187210
- Exp. Date: 2/1/2017.
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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