Smiths Medical Spinal Tray Recalled Due to Manufacturing Temperature Deviations
McKesson Medical-Surgical recalls Smiths Medical spinal trays due to manufacturing temperature deviations. Approximately 8 cases were 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 manufacturing non-compliance (temperature deviation). No reported illnesses, injuries, or deaths. Potential quality risk from manufacturing defect to a medical device meets the rubric criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Smiths Medical ASD spinal trays (model A4058-25, 25G Whitacre, no epinephrine) due to current Good Manufacturing Practice (cGMP) deviations. The product experienced temperature deviations during manufacturing that did not meet specifications.
The recall affects approximately 8 cases distributed throughout the United States. McKesson Medical-Surgical has stated it cannot identify which specific lot numbers were received by particular customers; customer notification letters include the distribution dates and shipment timeframes relevant to each order.
Healthcare facilities and professionals who received this product should consult their notification from McKesson for guidance on affected shipments and lot numbers. Patients who received procedures using this product do not require immediate action unless advised otherwise by their healthcare provider.
Any adverse events associated with this product may be reported to the FDA's MedWatch program.
The recalled product
- Product
- Spinal Tray (A4058-25 Spinal Tray 25G Whitacre No Epinephrine), Rx only, Manufacturer: Smiths Medical ASD, Inc., NJ
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Medical Device — Spinal Tray
- Affected units
- 8
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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