Recall Z-0189-2016
Resource Optimization & Innovation Llc · initiated August 25, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical kit for surgery.
Codes / lots: 26550
Reason for recall
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
FDA-determined cause: Packaging
Action taken
On August 25, 2015, the recalling firm sent an email to their direct customers informing them of the recall. The email instructed their customers to examine their inventory and determine whether they had any of the affected devices. The recalling firm attached the recall notice they received from their supplier. On September 4, 2015, the recalling firm sent a second email clarifying that they were instructing their customer to discard the supplier component . The notice also asked the customer to respond with how many affected devices they had in their inventory at the time they received the notice.
Details
- Recall number
- Z-0189-2016
- Initiated
- August 25, 2015
- Posted by FDA
- October 30, 2015
- Terminated
- April 6, 2017
- Product code
- LHC – Warmer, Irrigation Solution
- Quantity
- 17 kits
- Distribution
- Distributed in Texas and Louisiana.
- Recalling firm
- Resource Optimization & Innovation Llc, Springfield, MO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0184-2016 Class II | Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to… | 08/25/2015Terminated |
| Z-0185-2016 Class II | Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular…Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to… | 08/25/2015Terminated |
| Z-0186-2016 Class II | Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for…Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to… | 08/25/2015Terminated |
| Z-0187-2016 Class II | Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for…Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to… | 08/25/2015Terminated |
| Z-0188-2016 Class II | Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for…Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to… | 08/25/2015Terminated |
| Z-0190-2016 Class II | Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for…Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to… | 08/25/2015Terminated |
| Z-0191-2016 Class II | Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical kit for…Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to… | 08/25/2015Terminated |