Epidural Nerve Block Tray Recalled for Temperature Abuse
McKesson Medical-Surgical is recalling an Epidural Nerve Block Tray (model #182207) distributed nationwide due to temperature abuse during manufacturing that violates cGMP standards. The exposure may compromise device sterility required for safe epidural procedures.
The agency’s classification
FDA (Drugs): 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: This is an FDA Class II recall for a medical device with temperature exposure that compromises sterility. Although no illnesses or injuries have been reported, the product presents a risk of harm to patients undergoing epidural procedures due to potential contamination. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling the Epidural Tray, Nerve Block Single shot (model #182207), which is manufactured by Avanos Medical Sales LLC. This is a prescription-only medical device used for epidural anesthesia and nerve block procedures.
The recall was initiated due to cGMP (current Good Manufacturing Practices) deviations involving temperature abuse. The product was exposed to temperatures outside acceptable limits, which may compromise the device's sterility and structural integrity needed for safe clinical use.
One case of the recalled product was distributed nationwide throughout the United States. Because McKesson Medical-Surgical is unable to identify specific lot numbers for individual consignees, all potentially affected units may have been exposed to the temperature deviation.
Customers who received the recalled Epidural Tray should immediately discontinue use and contact McKesson Medical-Surgical Inc. for instructions on product return or proper disposal. Healthcare providers should verify receipt of this product and take appropriate action to ensure patient safety.
The recalled product
- Product
- Epidural Tray, Nerve Block Single shot, Rx only, # 182207, MFG: Avanos Medical Sales LLC
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 1
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) 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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