Non-sterile procedural trays labeled as CRANI, 2 per case
Reported: February 8, 2023 Initiated: November 17, 2022 #Z-1029-2023
Product Description
Non-sterile procedural trays labeled as CRANI, 2 per case
Reason for Recall
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
Details
- Recalling Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Units Affected
- 12 cases (24 units)
- Distribution
- US Nationwide distribution in the states of AR, MD, WA, WI.
- Location
- Northfield, IL
Frequently Asked Questions
What product was recalled? ▼
Non-sterile procedural trays labeled as CRANI, 2 per case. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 12 cases (24 units).
Why was this product recalled? ▼
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 8, 2023. Severity: Moderate. Recall number: Z-1029-2023.
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