McKesson Medi-Pak Laceration Trays Recalled for Incomplete Sterile Seals
Medical Action Industries is recalling 474 cases of McKesson Medi-Pak Laceration Trays because some sterile kits may have incomplete seals that could compromise sterility.
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 a defect (incomplete seal) could compromise sterility, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Medical Action Industries Inc is recalling 474 cases (9,480 units) of McKesson Medi-Pak Laceration Trays with Cotton O.R. Towels. The product is sterile, single-use, latex-free, and distributed by McKesson Medical Surgical, Inc. The specific model number is 25-2685, lot number 187211, with an expiration date of 12/1/2016.
The recall was initiated because some of the sterile kits may have incomplete seals. This defect might compromise the sterility of the kits, potentially exposing patients to infection risks during medical procedures.
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. Healthcare facilities and consumers who have this specific lot of laceration trays should stop using them and contact the distributor or manufacturer for instructions on return or replacement.
The recalled product
- Product
- McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single Use, Latex Free, 20 Each per Case, Rx only, Distributed by: McKesson Medical Surgical, Inc., Richmond, VA 23228
- 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: 25-2685
- Lot number: 187211
- 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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