Z-1833-2021 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 16, 2021
- Initiation Date
- May 14, 2021
- Termination Date
- April 21, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 66 packs
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
Distribution Pattern
US Nationwide distribution to the states of MS, VA, LA, and NY.
Code Information
Lot Numbers: 54310362, exp. 01/01/2022; 54366825, exp. 01/01/2022