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Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT NEUR FUS LUM POST, c...

FDA Device Recall #Z-1476-2022 — Class II — June 6, 2022

Recall Summary

Recall Number Z-1476-2022
Classification Class II — Moderate risk
Date Initiated June 6, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm MEDLINE INDUSTRIES, LP - SPT
Location Waukegan, IL
Product Type Devices
Quantity 2850 units

Product Description

Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT NEUR FUS LUM POST, c. KIT PEDI VP SHUNT, d. KIT STC NEURO SPINE GENERIC, e. MAIN BASIC NEURO, f. MAJOR NEURO PK-LF, g. NEURO, h. NEURO CERVICAL PACK, i. NINOR NEURO PK-LF, j. VP SHUNT PACK Model/Catalog Number: Model Numbers: a.DYNJ0397191V, b. DYKMBNDL138, c. DYNJ907374, d. DYKMBNDL40A, e. DYNJ908260, f. DYNJ21243M, g. DYNJ904818D, DYNJ905194, DYNJ904040D, DYNJ904040F, DYNJ904818C, DYNJ905753A, h. DYNJ0101287I, i. DYNJ21244N, j. DYNJ46530J

Reason for Recall

Kits contain leaking bottles of isopropyl alcohol

Distribution Pattern

US Nationwide distribution.

Lot / Code Information

Lot Code: a. Model Number DYNJ0397191V, Lot Numbers: 22CDC076, 22ADB021, 21KDC417, 21KDB423, 21GDA239, 21KDA879; b. Model Number DYKMBNDL138, Lot Numbers: 22OBC508, 22DBD203, 22BBT015, 22NBA962, 21GBG761, 21GBS468, 21HBN643, 21JBB951, 21LBL164, 21DBE120, 21FBE311; c. Model Number DYNJ907374, Lot Numbers: 22ALA147, 21KLA187, 21LLA436, 21GMB680; d. Model Number DYKMBNDL40A, Lot Numbers: 22OBF727, 22EBA075, 21LBQ967, 21LBQ968, 22ABL295, 21FBP377, 21GBB010, 21IBD953, 21IBO781, 21JBT126, 21KBX882, 21CBM834, 21FBB095; e. Model Number DYNJ908260, Lot Numbers: 22DBE642, 22ABS925, 22OBA019, 21KBX711, 21LBB504; f. Model Number DYNJ21243M, Lot Numbers: 22OBJ131, 21FBR040, 21HBP246, 21HBP293, 21LBJ604; g. Model Number DYNJ904818D, Lot Numbers: 22OBM370, 22BBL695, 21JBM657, 21JBX775, 21LBO565, 21LBP608; g. Model Number DYNJ905194, Lot Numbers: 19HBK497; g. Model Number DYNJ904040D, Lot Numbers: 21EBC547, 21FBF247; g. Model Number DYNJ904040F, Lot Numbers: 22ABP680, 22OBA915, 22OBE643, 21VBB536; g. Model Number DYNJ904818C, Lot Numbers: 21FBI236, 21HBF322; g. Model Number DYNJ905753A, Lot Numbers: 22BBD850, 22BBD854, 21FBS310; h. Model Number DYNJ0101287I, Lot Numbers: 22CDC182, 22BDA782, 21LDA070, 21KDA985, 21EDA767, 21GDC130, 21HDA996; i. Model Number DYNJ21244N, Lot Numbers: 22NBA715, 22CBS112, 21GBG678, 21IBL346, 21FBF231; j. Model Number DYNJ46530J, Lot Numbers: 22CBD976, 21JBX562, 21KBG431

Other Recalls from MEDLINE INDUSTRIES, LP - SPT

Recall # Classification Product Date
Z-1470-2022 Class II Medline Convenience kits labeled as follows: a... Jun 6, 2022
Z-1471-2022 Class II Medline convenience kits: a. VENOUS ACCESS PAC... Jun 6, 2022
Z-1475-2022 Class II Medline Convenience kits labeled as: a. WET SK... Jun 6, 2022
Z-1477-2022 Class II Jun 6, 2022
Z-1474-2022 Class II Medline Convenience kits labeled as: a. MAJOR ... Jun 6, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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