FDA recall Z-0523-2018

Product

Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches are packaged 10 each inside a poly liner. 5 rows of 10 pouches are placed in a labeled corrugated mailer box. Product Usage: Intended to be used as a disposable barrier for a surgical lighting system and which allows a surgical team member to manually adjust the lighting system. Single use device.

Reason for recall

Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch.

Distribution

Distributed domestically to Michigan.

Key facts

Status

Terminated

Initiation date

2017-10-13

Report date

2018-02-14

Termination date

2020-07-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0523-2018