DeRoyal Pacemaker Tray Mislabeled With Wrong Anesthetic Concentration
DeRoyal is recalling surgical procedure packs due to mislabeling. The product contains 0.5% Bupivacaine but is labeled as 1% Lidocaine, creating a medication identification error.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which requires a minimum severity score of 4. Although no deaths or serious injuries have been reported, the Class I designation reflects the serious nature of medication mislabeling in surgical products.
Plain-English summary
DeRoyal Industries Inc is recalling certain lots of surgical procedure packs (DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06, Lot Number 54239375, expiration 02/01/2022, quantity 12 trays). The packs are mislabeled: they contain 0.5% Bupivacaine but are labeled as containing Hospira Pfizer 1% Lidocaine.
The discrepancy between the actual product and the label creates a medication identification hazard in the surgical setting.
The affected products were distributed nationwide to healthcare facilities in Mississippi, Virginia, Louisiana, and New York. Customers with these products should discontinue use and contact DeRoyal Industries Inc.
The recalled product
- Product
- DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- Affected units
- 12
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 (2)
- Lot Number 54239375
- exp. 02/01/2022
Distribution
Part of a larger recall action
This product is one of 3 recalled by DeRoyal 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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