Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO FUS LUM POST SANSUR, d. KIT NE
Summary
The FDA issued a Class II for Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. by MEDLINE INDUSTRIES, LP - SPT. Reason: Kits contain leaking bottles of isopropyl alcohol.
Details
Source
Device Recall
External ID
Z-1474-2022
Action Date
2022-08-03
Status
Ongoing
Category
device
Product Description
Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO FUS LUM POST SANSUR, d. KIT NEURO FUS LUM POST SANSUR , e. PRE-OP ACCESSORY KIT CHOICE, f. DEEP BRAIN STIMULATION PACK, g. DEEP BRAIN STIMULATION PACK, h. MINIMALLY INVASIVE PACK-LF, i. EVLP Pack/Kit, j. GENERAL PURPOSE CV, k. GENERAL PURPOSE CV, l. KIT GERMANTOWN CABG, m. KIT GERMANTOWN CABG, n. DENTAL RESTORATIONS, o. ALCOHOL PREP PACK, p. ALCOHOL PREP PACK, q. MATRIXECTOMY PACK-LF Model/Catalog Number: a. CDS981543D, b. DYKM1875, c. DYKMBNDL142A, d. DYKMBNDL142A, e. DYKS1185A, f. DYNJ0842793F, g. DYNJ0842793F, h. DYNJ0843063J, i. DYNJ901205C, j. DYNJ904395F, k. DYNJ904395F, l. DYNJ905855, m. DYNJ905855, n. DYNJ906653A, o. P922260, p. P922260, q. PHS110395003
Lot/Code Info: Lot Code: a. Model Number CDS981543D, Lot Numbers: 19HBK745; b. Model Number DYKM1875, Lot Numbers: 22ABK810, 22ABO583, 21LBB378; c. Model Number DYKMBNDL142A, Lot Numbers: 22OBJ742, 22ABY101, 21FBQ232, 21HBG594, 21JBA902, 21VBC259, 21DBE917; d. Model Number DYKS1185A, Lot Numbers: 21LBX041, 22CBO060, 21HBI534, 21HBQ840, 21CBT064, 21CBZ524; e. Model Number DYNJ0842793F, Lot Numbers: 22BDB295, 22DDA792, 21EDA769, 21GDB289, 21HDC822; f. Model Number DYNJ0843063J, Lot Numbers: 22CDB166, 22ADC136, 21LDA151, 21EDC220, 21GDC682, 21IDA570, 21JDA064; g. Model Number DYNJ901205C, Lot Numbers: 19HBE998; h. Model Number DYNJ904395F, Lot Numbers: 22DBG340, 22DBH356, 22DBI433, 21GBM221, 21LBO497, 21LBO625, 21DBJ932; i. Model Number DYNJ905855, Lot Numbers: 22DBK812, 22NBE430, 21GBC672, 21GBI192, 21IBT387, 21VBB580, 21DBV520, 21FBG162; j. Model Number DYNJ906653A, Lot Numbers: 22CDB173, 21CDC622; k. Model Number P922260, Lot Numbers: 22DMB774, 22BBK027, 21GBQ268, 21KBS110, 21CBZ538, 21EBI098; l. Model Number PHS110395003, Lot Numbers: 21HBB233, 21CBZ815
Quantity Affected: 6569 units
Reason for Recall
Kits contain leaking bottles of isopropyl alcohol
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-06
Company
Waukegan, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 163 device recalls issued in the same week, part of 403 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - SPT has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - SPT) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - SPT have FDA actions?
MEDLINE INDUSTRIES, LP - SPT has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1474-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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