FDA recall Z-2221-2019

Product

Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.

Reason for recall

Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.

Distribution

Distributed to LA and MO

Key facts

Status

Ongoing

Initiation date

2019-03-21

Report date

2019-08-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Springfield, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2221-2019