DeRoyal Heart Cath Procedure Packs Recalled for Anesthetic Mislabeling
DeRoyal Industries is recalling 66 heart catheterization procedure packs due to mislabeling of anesthetic contents. The packs contain 0.5% Bupivacaine but are labeled as containing 1% Lidocaine, creating a medication error risk during surgery.
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 medical device recall, which establishes a minimum severity of Severe per the rubric. The mislabeling of a critical anesthetic agent in a cardiac catheterization procedure pack creates a direct medication error risk in a surgical setting.
Plain-English summary
DeRoyal Industries Inc is recalling 66 units of Heart Cath Procedure Packs (REF 89-6556.08) due to mislabeling of the anesthetic agent included in the pack. The procedure packs contain 0.5% Bupivacaine but are labeled and distributed with information indicating 1% Lidocaine, creating a medication identification and dosing risk.
These procedure packs were distributed to healthcare facilities in Mississippi, Virginia, Louisiana, and New York. The affected lot numbers are 54310362 and 54366825, both with expiration dates of 01/01/2022.
This mislabeling creates a significant risk of medication error if surgical teams rely on the labeled information when administering anesthesia during cardiac catheterization procedures. The use of the wrong anesthetic or incorrect dosing based on the label could lead to patient harm.
Healthcare facilities should immediately identify and quarantine the affected packs and cease their use. Affected packs should be returned to DeRoyal Industries Inc.
The recalled product
- Product
- DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 66
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 (3)
- Lot Numbers: 54310362
- exp. 01/01/2022
- 54366825
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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