DeRoyal Heart Cath Procedure Pack recall: Labeling Error
DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
Why was DeRoyal Heart Cath Procedure Pack recalled?
DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 54310362, exp. 01/01/2022; 54366825, exp. 01/01/2022
- Product
- DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 66 packs
- Distribution
- US Nationwide distribution to the states of MS, VA, LA, and NY.
- Recall date
- June 16, 2021
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)