Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.
FDA device recall Z-2798-2015 · posted 2015-09-21 · Terminated
Recall details
- Recalling firm
- Resource Optimization & Innovation Llc
- Reason for recall
- Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.
- Action taken
- On 8/19/2015, the recalling firm sent its two consignees an email with the recall notice attached. The notice notified their customers that they were affected by the recalling firm's supplier's recall. The notice instructed the customers to dispose of the recalled component and acknowledge receipt of the recall notice.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- LRO
- Quantity affected
- 24 kits
- Distribution
- Distributed to one customer in Lake Charles, LA and one customer in Spartanburg, SC.
- Date initiated
- 2015-08-19
- Date posted
- 2015-09-21
- Date terminated
- 2017-04-05
- Location
- Springfield, MO
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