FDA recall Z-1833-2021

Product

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

US Nationwide distribution to the states of MS, VA, LA, and NY.

Key facts

Status

Terminated

Initiation date

2021-05-14

Report date

2021-06-16

Termination date

2023-04-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Powell, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1833-2021