Medical Device Recall: Z-0039-2016

FDA Recalls dataset · Firm: Resource Optimization & Innovation Llc · Status: Terminated

Recall Action Class: N/A Date Initiated: 2015-04-22 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0039-2016.

Recall Res Number
Z-0039-2016
Recalling Firm / Manufacturer
Resource Optimization & Innovation Llc
FEI Number
3004513970
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2015-04-22
Date Posted
2015-10-07
Date Terminated
2017-03-28
Product Code
FSY
Event Number
71904
Product Quantity
400 kits
Product Description regard Item Number: 800417, Sterile, GY0486 - Laparoscopy 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
Reason for Recall The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Action Details 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.
Distribution Pattern Distribution was made to LA, MS, and TX.
Code Information / Serial Numbers Lot numbers 14886, 18136, 19831, 22808, and 23940.

Related Establishments / Registrations

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