FDA recall Z-2576-2018

Product

Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.

Reason for recall

Product contains dry natural rubber latex. Label states Latex Free.

Distribution

Puerto Rico

Key facts

Status

Terminated

Initiation date

2018-05-23

Report date

2018-08-08

Termination date

2020-05-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Reading, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2576-2018