Z-1476-2022Class II

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

Name: Z-1476-2022 Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT NEUR FUS LUM POST, c. KIT PEDI VP...
Creator: Medline Industries, Lp - Spt
Published: 2022-06-06
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-06-06 / Open, Classified

FDA source

MEDLINE INDUSTRIES, LP - SPT began a recall of 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... on 2022-06-06. FDA classified it as Class II and gives the reason as "Kits contain leaking bottles of isopropyl alcohol". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1476-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-06
Posted: 2022-07-27
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: 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
Product code: OJG Neurological Tray
Reason for recall: Kits contain leaking bottles of isopropyl alcohol
FDA root cause: Under Investigation by firm
Action: The firm's consignees were notified by US mail on 06/06/2022 and instructed to destroy any affected kits on hand in accordance with their local and state regulations.
Quantity in commerce: 2850 units
Distribution: US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1476-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1470-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-27
Z-1471-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-27
Z-1472-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-27
Z-1473-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-27
Z-1474-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-27
Z-1475-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-27
Z-1476-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-27
Z-1477-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-27

Product code OJG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)