FDAClass IIAugust 3, 2022

Medline Custom procedural kits labeled as follows: a. recall

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…

Why was Medline Custom procedural kits labeled as follows: a. recalled?

Kits contain leaking bottles of isopropyl alcohol

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
MEDLINE INDUSTRIES, LP - SPT
Quantity
2850 units
Distribution
US Nationwide distribution.
Recall date
August 3, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls