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
FDA Recall Z-1476-2022 · Posted None
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Recalling FirmMEDLINE INDUSTRIES, LP - SPT
Recall StatusOpen, Classified
Product CodeOJG
Date Initiated2022-06-06
Product Quantity2850 units
Reason for Recall
Kits contain leaking bottles of isopropyl alcohol
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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