Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum saw blades.
Reported: March 3, 2021 Initiated: January 25, 2021 #Z-1139-2021
Product Description
Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum saw blades.
Reason for Recall
Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
Details
- Recalling Firm
- DeRoyal Industries Inc
- Units Affected
- 1084 packs
- Distribution
- Distributors in OK, MI, and TX.
- Location
- Powell, TN
Frequently Asked Questions
What product was recalled? ▼
Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum saw blades.. Recalled by DeRoyal Industries Inc. Units affected: 1084 packs.
Why was this product recalled? ▼
Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 3, 2021. Severity: Moderate. Recall number: Z-1139-2021.
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