FDA Recalls DeRoyal Pacemaker ICD Pack, Lot 57898501
DeRoyal Industries voluntarily recalled 75 units of its PACEMAKER ICD PACK (REF 89-10216.06, Lot 57898501) distributed across 23 US states on November 3, 2022.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall initiated voluntarily by the firm with no reported illnesses or injuries. Classified as a precautionary measure.
Plain-English summary
DeRoyal Industries Inc issued a voluntary recall of its PACEMAKER ICD PACK (model REF 89-10216.06). The recall affects 75 kits distributed across 23 US states. The FDA classified this recall as Class II.
Affected units are from Lot 57898501, with an expiration date of March 1, 2027. The recall was initiated on November 3, 2022.
Patients and healthcare providers who have received units from this lot should contact DeRoyal Industries Inc for additional information about the recall and guidance on next steps. Patients should not discontinue use of their devices without consulting their healthcare provider.
The recalled product
- Product
- DeRoyal PACEMAKER ICD PACK, REF 89-10216.06
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 75
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 (1)
- Lot Numbers: Lot 57898501 exp 3/1/2027
Distribution
Part of a larger recall action
This product is one of 156 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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