Device product
DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
Z-1833-2021
Product summary
- Event
- Event 87949
- Status
- Terminated
- Classification
- Class I
- Quantity
- 66 packs
- Official record key
device-enforcement:Z-1833-2021
Official wording
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
Code information: Lot Numbers: 54310362, exp. 01/01/2022; 54366825, exp. 01/01/2022
Distribution pattern: US Nationwide distribution to the states of MS, VA, LA, and NY.
Derived failure modes
-
Labeling or packaging
mislabeling