Recall Z-0092-2016 ยท FSY Light, Surgical, Ceiling Mounted
Resource Optimization & Innovation Llc
regard Item Number: 800411002, Sterile, NU0480B - Neuro Pk - 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
| Date | Oct 7, 2015 (initiated Apr 22, 2015) |
| Status | Terminated |
| Reason | The kits contain an equipment glove component which may contain splits or holes compromising the sterility. |
| Root cause | Process control |
| Action | 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 ha |
| Quantity | 214 kits |
| Distribution | Distribution was made to LA, MS, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.