PlainRecalls
FDA Devices Moderate Class II Ongoing

Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, REF DYNJ80585B.

Reported: January 8, 2025 Initiated: November 21, 2024 #Z-0789-2025

Product Description

Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, REF DYNJ80585B.

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.

Details

Units Affected
1494 units
Distribution
Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, REF DYNJ80585B.. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 1494 units.
Why was this product recalled?
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 8, 2025. Severity: Moderate. Recall number: Z-0789-2025.