Z-0186-2016Class II
Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery
Resource Optimization & Innovation, LLC / initiated 2015-08-25 / Terminated / root cause: packaging
Resource Optimization & Innovation Llc began a recall of Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery on . FDA classified it as Class II and gives the reason as "Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-0186-2016
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Resource Optimization & Innovation, LLC
- Product
- Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.
- Product code
- LHC Warmer, Irrigation Solution
- 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.
- Root cause tag
- packaging
- FDA root cause
- Packaging
- Action
- 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.
- Quantity in commerce
- 77 kits
- Distribution
- Distributed in Texas and Louisiana.
- Product codes and lots
- 24641
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0184-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0185-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0186-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0187-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0188-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0189-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0190-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0191-2016 | Class II | Terminated | Voluntary: Firm initiated |
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