FDAClass IAugust 14, 2024

Medline procedure kits labeled as: 1) WMC HYBRID OR recall

Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ; 2) VASCULAR PACK , Pack Number CMPJ11455B ; 3) SALEM CATH…

Why was Medline procedure kits labeled as: 1) WMC HYBRID OR recalled?

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

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?

CMPJ08068F , Lot Number 24ABN950 ; CMPJ11455B , Lot Number 23IBD357 ; DYNJ26938J , Lot Number 22FBD709 ; DYNJ26938J , Lot Number 22GBH459 ; DYNJ26938J , Lot Number 22HBR225 ; DYNJ26938J , Lot Number 22IBJ562 ; DYNJ26938J , Lot Number 22JBP469 ; DYNJ26938J , Lot Number 23ABM365 ; DYNJ26938J , Lot Number 23CBM109 ; DYNJ26938J , Lot Number 23DBN340 ; DYNJ26938J , Lot Number 23GBH016 ; DYNJ26938J , Lot Number 23IBS867 ; DYNJ53018, Lot Number 21IBX266 ; DYNJ53018, Lot Number 22GBN555 ; DYNJ53018, Lot Number 23ABN207 ; DYNJ57729C , Lot Number 23HBK882 ; DYNJ57729C , Lot Number 24ABO025 ; DYNJ66856, Lot Number 21KBH003 ; DYNJ66856A , Lot Number 22DBD158 ; DYNJ66856A , Lot Number 22FBY433 ; DYNJ66856A , Lot Number 22GBK576 ; DYNJ66856A , Lot Number 22HBQ139 ; DYNJ66856A , Lot Number 22IBO303 ; DYNJ66856A , Lot Number 22JBO861 ; DYNJ66856A , Lot Number 22JBQ914 ; DYNJ66856A , Lot Number 23ABT952 ; DYNJ66856A , Lot Number 23CBF157 ; DYNJ66856A , Lot Number 23EBE461 ; DYNJ66856A , Lot Number 23EBI477 ; DYNJ66856A , Lot Number 23HBD973 ; DYNJ81061A , Lot Number 23HBN396 ; DYNJ84617, Lot Number 23FBR368 ; DYNJ49920L , Lot Number 23KMB066 ; UVT1190A , Lot Number 23BLA187 ; UVT1190A , Lot Number 23DLA246 ; UVT1190A , Lot Number 23KLA117 ; UVT1190A , Lot Number 23LLA329

Product
Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ; 2) VASCULAR PACK , Pack Number CMPJ11455B ; 3) SALEM CATH…
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
1,679,067 units in total
Distribution
Worldwide Distribution: US (nationwide) and OUS countries of: AE, AI, BB, CA, CL, CY, DE, GT, HN, JP, MX, MY, PA, PE, PR, SA, SG, TC, TT, VI, PR, TT, MX, BM, ES, NI, DO, GU, CR, AT, CD, DE, DF, W, and ON.
Recall date
August 14, 2024
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls