FDA recall Z-0365-2020

Cadence Science, Inc. · Class II · device

Product

Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (GTIN #816329023404); 5341 (GTIN #816329023411); 5342 (GTIN #816329023428); 5343 (GTIN #816329023435) - Product Usage: General Hospital Use

Reason for recall

The glass syringe used with Pressure Control Syringes may potentially break during use.

Distribution

US Nationwide distribution in the states of AL, AR, CA, FL, GA, IA, ID, IL, MO, NH, NJ, NY, OH, PA, SC, TX, VA, and WI.

Key facts

Status
Terminated
Initiation date
2019-05-10
Report date
2019-11-20
Termination date
2020-06-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cranston, RI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0365-2020