Bone Marrow Biopsy Tray with Lidocaine Hydrochloride Recalled for Temperature Abuse
McKesson is recalling Bone Marrow Biopsy Trays with Lidocaine due to cGMP deviations from temperature abuse. Product was distributed nationwide.
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: FDA Class II recall for temperature abuse of a sterile pharmaceutical product. While no illnesses or injuries have been reported, temperature deviations pose a direct risk of harm to sterility and medication efficacy, matching the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Bone Marrow Biopsy and Aspiration Trays containing Lidocaine Hydrochloride USP, 1%, 5mL. The recalled product is Item No. 11GX4, distributed in cases of 10, with 4 cases affected in this recall.
The recall is due to cGMP (current Good Manufacturing Practice) deviations involving temperature abuse. This deviation may compromise the sterility and efficacy of the medication included with the biopsy tray.
The affected product was distributed nationwide throughout the United States. McKesson Medical-Surgical has stated it cannot identify which specific lot numbers were received by particular customers. Each recall notification letter includes the distribution date and the dates the affected product may have been shipped to customers.
The recalled product
- Product
- Biopsy and Aspiration Tray Bone Marrow Illinois 11GX4 (10/cs) Rx CRFPED Lidocaine Hydrochloride USP, 1%, 5mL, Rx only, MFG: Becton Dickinson
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 4
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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