Sterile, GY0486 Laparoscopy Pk surgical kit 의 리콜

Recall

71904

Class 2

Z-0039-2016

2015-04-22

2015-10-07

Terminated

United States

2017-03-28

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139754

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

ROi initiated a recall of the custom kits via e-mail to their customers on April 22, 2015. The e-mail included their recall letter dated April 17, 2015. and the supplier's recall letter dated April 16, 2015. The customer was requested to discard the recalled component from their procedure tray at the time of set up and replace it with sterile stock. Customers were instructed to contact any ROi custom pack solutions manager with any concerns. The recalling firm issued a second e-mail notification on 10/19/2015 to the recall coordinator of the distributor. The notice informed them they had been receiving uncorrected product and reminded them to discard the defective component at the time the kit is set up for surgery. Any future distribution will be labeled with an alert to remove the defective component until the kits contain acceptable light handle covers. For questions regarding this recall call 314-364-6561.