Recall Z-0778-2025— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-11-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; 3) RFD- AAA PACK, REFDYNJ54242B; 4) OPEN HEART A&B, REFDYNJ901203C; 5) OPEN HEART A&B, REFDYNJ901203D; 6) ACDF-LF, REFDYNJ906681B; 7) ACDF-LF, REFDYNJ906681C.. Reason: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-11-21
- Firm location
- Northfield, IL, United States
Product description
Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; 3) RFD- AAA PACK, REFDYNJ54242B; 4) OPEN HEART A&B, REFDYNJ901203C; 5) OPEN HEART A&B, REFDYNJ901203D; 6) ACDF-LF, REFDYNJ906681B; 7) ACDF-LF, REFDYNJ906681C.
Reason for recall
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Data sourced from openFDA. This site is unofficial and independent of the FDA.