—#139873

Product

regard Item Number: 880327002, sterile, CV0758B - Open Heart A&B - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

FDA product code: FSY — Light, Surgical, Ceiling Mounted
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot numbers 24298 and 24572.

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Resource Optimization & Innovation Llc
Address: 2909 N Neergard Ave, Springfield, Missouri 65803

Distribution

Distribution pattern: Distribution was made to LA, MS, and TX.

Timeline

Recall initiated: 2015-04-22
Posted by FDA: 2015-10-07
Terminated: 2017-03-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139873. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.