FDA recall Z-1981-2019

Product

DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack

Reason for recall

Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which were recalled due to a manufacturing defect in the cartridge component which could compromise the sterility barrier of the product.

Distribution

US Distribution to: OK

Key facts

Status

Terminated

Initiation date

2019-06-18

Report date

2019-07-24

Termination date

2020-09-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Powell, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1981-2019