FDA Device Recall Z-2444-2024

MEDLINE INDUSTRIES, LP - Northfield · Northfield, IL

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ; 2) VASCULAR PACK , Pack Number CMPJ11455B ; 3) SALEM CATH LAB-LF , Pack Number DYNJ26938J ; 4) EH PEDIATRIC CATH , Pack Number DYNJ49920L ; 5) ARTERIOGRAM PACK, Pack Number DYNJ53018; 6) CATH PACK , Pack Number DYNJ57729C ; 7) PEDS CATH PACK, Pack Number DYNJ66856; 8) PEDS CATH PACK, Pack Number DYNJ66856A ; 9) STEWARD ROCKLEDGE CATH RRS, Pack Number DYNJ81061A ; 10) CATH LAB PACK , Pack Number DYNJ84617; 11) UA/UV CATHETERIZATION TRAY, Pack Number UVT1190A

Lot / serial / GTIN: 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

Quantity: 1,679,067 units in total

Reason for recall

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.

Recall record

Recall number: Z-2444-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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 initiated: 2024-04-08
Classified by FDA Center: 2024-08-08
FDA published: 2024-08-14
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Firm location: Northfield, IL

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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