FDA recall Z-2473-2021

Cypress Medical Products LLC · Class II · device

Product

McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121

Reason for recall

Manufacturer issued a recall due to an EO indicator color. The indicator should change from red to blue signifying sterilization. However, on one case of product, the indicators did not change

Distribution

VA

Key facts

Status
Terminated
Initiation date
2021-08-11
Report date
2021-09-22
Termination date
2023-07-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Richmond, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2473-2021