Recall Z-0075-2016
Resource Optimization & Innovation Llc · initiated April 22, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular - 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
Codes / lots: Lot numbers 18390, 18746, 19702, and 20713.
Reason for recall
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0075-2016
- Initiated
- April 22, 2015
- Posted by FDA
- October 7, 2015
- Terminated
- March 28, 2017
- Product code
- FSY – Light, Surgical, Ceiling Mounted
- Quantity
- 64 kits
- Distribution
- Distribution was made to LA, MS, and TX.
- Recalling firm
- Resource Optimization & Innovation Llc, Springfield, MO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0028-2016 Class II | regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0029-2016 Class II | regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0030-2016 Class II | regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0031-2016 Class II | regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0032-2016 Class II | regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0033-2016 Class II | regard Item Number: 800410, Sterile, CV0479 - Open Heart Pk - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0034-2016 Class II | regard Item Number: 800411, Sterile, NU0480 - Neuro Pk - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0035-2016 Class II | regard Item Number: 800413, Sterile, CV0482 - Vascular Pk - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0036-2016 Class II | regard Item Number: 800414, Sterile, OR0483 - Total Joint Pk - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0037-2016 Class II | regard Item Number: 800415, Sterile, OR0484 - Shoulder System Pk - surgical kit…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0038-2016 Class II | regard Item Number: 800416, Sterile, GY0485 - Robotic Hysterectomy Pkg - surgical kit…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0039-2016 Class II | regard Item Number: 800417, Sterile, GY0486 - Laparoscopy Pk - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0040-2016 Class II | regard Item Number: 800418, Sterile, GY0487 - Major Vaginal Pk - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0041-2016 Class II | regard Item Number: 800419, Sterile, GY0488 - D&C Pk - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0042-2016 Class II | regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0043-2016 Class II | regard Item Number: 800425, Sterile, CV0494 - AV Access Pk -Spohn surgical kit…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0044-2016 Class II | regard Item Number: 800508, Sterile, LD0586 - C Section - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0045-2016 Class II | regard Item Number: 800514, Sterile, LD0592 - C Section Pack - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0046-2016 Class II | regard Item Number: 800524, Sterile, LD0608 - C Section - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0047-2016 Class II | regard Item Number: 800525, Sterile, OR0609 - Extremity Pack - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0048-2016 Class II | regard Item Number: 800526, Sterile, ET0610 - Head and Neck - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0049-2016 Class II | regard Item Number: 800527, Sterile, OR0611 - Hip Shoulder Pk - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0050-2016 Class II | regard Item Number: 800528, Sterile, GS0612 - Lap Chole Pk - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0051-2016 Class II | regard Item Number: 800531, Sterile, NU0615 - Neuro Pk - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0052-2016 Class II | regard Item Number: 800532, Sterile, GY0616 - Vaginal Hysterectomy - surgical kit…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0053-2016 Class II | regard Item Number: 800533, Sterile, GS0606 - Abdominal Pk - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0054-2016 Class II | regard Item Number: 800535, Sterile, LD0620 - C Section - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0055-2016 Class II | regard Item Number: 800546, Sterile, GS0635 - Abdominal - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0056-2016 Class II | regard Item Number: 800548, Sterile, OR0637 - Extremity - surgical kit containing cover…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |
| Z-0057-2016 Class II | regard Item Number: 800549, Sterile, ET0638 - Head & Neck - surgical kit containing…The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 04/22/2015Terminated |