FDA Recall
Terminated
Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packs including sternum saw blades.
Recall: Z-1140-2021
·
Initiated January 25, 2021
Recall
- Recall Number
- Z-1140-2021
- Event Number
- 87218
- Firm
- DeRoyal Industries Inc
- FEI Number
- 1043214
- Product Code
- LRO
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- January 25, 2021
- Terminated
- July 21, 2022
- Address
- 200 Debusk Ln, Powell, TN, 37849-4703
Description
Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packs including sternum saw blades.
Reason
Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
Action
DeRoyal issued their recall on 01/25/2021 to the end user level by emailing recall letters to its direct accounts. The direct accounts were instructed to forward our recall notification to their customers. The direct accounts and their customers were asked to identify the affected products and return the provided notice of credit form back to DeRoyal.
Distribution
Distributors in OK, MI, and TX.
Quantity
776 packs