Recall Z-1833-2021— DeRoyal Industries Inc
Class I · Terminated
Class I FDA medical device recall by DeRoyal Industries Inc, initiated 2021-05-14, terminated 2023-04-21. FDA's recall record names no specific 510(k) clearance for this event. Product: DeRoyal Heart Cath Procedure Pack, REF 89-6556.08. Reason: 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.
- Recalling firm
- DeRoyal Industries Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2021-05-14
- Terminated
- 2023-04-21
- Firm location
- Powell, TN, United States
Product description
DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.