Recall Z-1476-2022
Medline Industries, LP - SPT · initiated June 6, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / 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…
Reason for recall
Kits contain leaking bottles of isopropyl alcohol
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1476-2022
- Initiated
- June 6, 2022
- Product code
- OJG – Neurological Tray
- Quantity
- 2850 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Medline Industries, LP - SPT, Waukegan, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1470-2022 Class II | Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number…Kits contain leaking bottles of isopropyl alcohol | 06/06/2022Open, Classified |
| Z-1471-2022 Class II | Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes:…Kits contain leaking bottles of isopropyl alcohol | 06/06/2022Open, Classified |
| Z-1472-2022 Class II | Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ0689093V, b. EENT…Kits contain leaking bottles of isopropyl alcohol | 06/06/2022Open, Classified |
| Z-1473-2022 Class II | Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE Model/Catalog…Kits contain leaking bottles of isopropyl alcohol | 06/06/2022Open, Classified |
| Z-1474-2022 Class II | Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO…Kits contain leaking bottles of isopropyl alcohol | 06/06/2022Open, Classified |
| Z-1475-2022 Class II | Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRAY W/CHG…Kits contain leaking bottles of isopropyl alcohol | 06/06/2022Open, Classified |
| Z-1477-2022 Class II | Kits contain leaking bottles of isopropyl alcohol | 06/06/2022Open, Classified |