FDA recall Z-0353-2020

Heritage Medical Products, Inc. · Class II · device

Product

2000 Vascular with 30 Degree option

Reason for recall

Potential for bed to drop suddenly at the head while a patient is laying on it.

Distribution

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, OH, OK, OR, PA, SC, TX, UT, VA, WI, WY, PR. International distribution to Canada, Saudi Arabia, Trinidad & Tobago.

Key facts

Status
Terminated
Initiation date
2016-09-02
Report date
2019-11-20
Termination date
2020-12-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
West Plains, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0353-2020