DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
Reported: June 16, 2021 Initiated: May 14, 2021 #Z-1833-2021
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
Details
- Recalling Firm
- DeRoyal Industries Inc
- Units Affected
- 66 packs
- Distribution
- US Nationwide distribution to the states of MS, VA, LA, and NY.
- Location
- Powell, TN
Frequently Asked Questions
What product was recalled? ▼
DeRoyal Heart Cath Procedure Pack, REF 89-6556.08. Recalled by DeRoyal Industries Inc. Units affected: 66 packs.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 16, 2021. Severity: Critical. Recall number: Z-1833-2021.
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