FDA recall Z-2601-2018

Covidien LLC · Class II · device

Product

Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955

Reason for recall

Potential proplylene glycol contamination

Distribution

CA, NY & TX

Key facts

Status
Terminated
Initiation date
2018-06-15
Report date
2018-08-08
Termination date
2019-05-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
North Haven, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2601-2018