Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.
Reported: March 26, 2025 Initiated: February 13, 2025 #Z-1370-2025
Product Description
Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.
Reason for Recall
Potential breach in pouch packaging which could lead to loss of sterility.
Details
- Recalling Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Units Affected
- 1,118 units
- Distribution
- US Nationwide distribution.
- Location
- Northfield, IL
Frequently Asked Questions
What product was recalled? ▼
Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 1,118 units.
Why was this product recalled? ▼
Potential breach in pouch packaging which could lead to loss of sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 26, 2025. Severity: Moderate. Recall number: Z-1370-2025.
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