Surgical procedure pack anesthetic mislabeled with wrong drug and strength
DeRoyal Angio Cath Removal Tray contains mislabeled anesthetic; the label indicates 1% Lidocaine but the tray actually contains 0.5% Bupivacaine. This FDA Class I recall affects 60 trays distributed in MS, VA, LA, and NY.
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: FDA Class I classification requires a minimum severity rating of Severe (4). The anesthetic mislabeling—specifically incorrect drug identity and concentration—poses a direct medication safety risk to patients, though no illnesses or deaths are reported in the source text.
Plain-English summary
DeRoyal Industries Inc is recalling the DeRoyal Angio Cath Removal Tray (REF 89-9936.02) due to anesthetic mislabeling. The product is labeled as containing 1% Lidocaine, but actually contains 0.5% Bupivacaine.
Lot 54368716 (expiration 6/01/2022) contains this discrepancy, affecting 60 trays with nationwide distribution to Mississippi, Virginia, Louisiana, and New York. This mislabeling means the wrong medication and concentration are present in the surgical procedure pack.
Users of this product should immediately discontinue use and contact DeRoyal Industries Inc. The mismatch between labeled and actual anesthetic creates a medication safety risk during surgical procedures.
The recalled product
- Product
- DeRoyal Angio Cath Removal Tray, REF 89-9936.02
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 60
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 Numbers: 54368716
- exp. 6/01/2022
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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