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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Custom procedural kits

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 Class 2 Device Recall Medline Custom procedural kitssee related information
Date Initiated by FirmJune 06, 2022
Create DateJuly 27, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1476-2022
Recall Event ID 90516
Product Classification Neurological tray - Product Code OJG
ProductMedline 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
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
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - SPT
1170 S Northpoint Blvd
Waukegan IL 60085-6757
For Additional Information ContactKassandra Cotner
866-775-6072
Manufacturer Reason
for Recall		Kits contain leaking bottles of isopropyl alcohol
FDA Determined
Cause 2		Under Investigation by firm
ActionThe 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 Commerce2850 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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