Recall Z-2798-2015 ยท LRO General Surgery Tray
Resource Optimization & Innovation Llc
Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.
| Date | Sep 21, 2015 (initiated Aug 19, 2015) |
| Status | Terminated |
| Reason | Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance. |
| Root cause | Material/Component Contamination |
| Action | 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. |
| Quantity | 24 kits |
| Distribution | Distributed to one customer in Lake Charles, LA and one customer in Spartanburg, SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.