FDA Device Recall Z-1112-2024

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 Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT21215; c) LACERATION TRAY, REF SUT15380; d) LACERATION TRAY W/SNAGFREE NEE, REF SUT19005; e) PLASTICS SUTURE TRAY, REF SUT13535; f) UVC INSERTION TRAY, REF UVT840A g) BRONCHOALVEOLAR LAVAGE PACK, REF DYNDA2369A; h) CENTRAL LINE NEEDLELESS CONNECTOR KIT, REF DYNDC2869B; i) CVC STERILE CAP CHANGE KIT, REF DT20900A; j) DOUBLE VALVE CHANGE KIT, REF DYNDA2660A; k) KIDNEY BIOPSY PACK, REF DYNDH1650; l) PORT ACCESS INFUSION KIT - 0.75IN NEEDLE, REF DYNDC2816C; m) PORT ACCESS KIT, REF EBSI1302A; n) SHORT TERM INFUSAPORT ACCESS KIT, REF DYNDC3188; o) SINGLE VALVE CHANGE KIT, REF DYNDA2659A; p) SUTURE TRAY, REF DYNDS1085A;

Lot / serial / GTIN: a) REF SUT13935, UDI/DI 40193489440714 (case), 10193489440713 (unit), Lot Numbers: 23GBO782, 23GBP869, 23HBA879, 23HBX374; b) REF SUT21215, UDI/DI 653160325645 (case), 10653160325642 (unit), Lot Numbers: 22EBB078, 22FBE772, 22GBJ917, 22HBN681, 22HBW656, 22JBB835, 23ABL668, 23FBT868, 23GBK697, 23HBU987; c) REF SUT15380, UDI/DI 10653160203698 (case), 653160203691 (unit), Lot Numbers: 22EBI572, 22FBK706, 22GBI140, 22GBZ790, 22JBT097, 22KBW287, 22LBS262, 23DBB365, 23EBB439, 23EBS520, 23FBV416, 23HBV213; d) REF SUT19005, UDI/DI 653160271454 (case), 10653160271451 (unit), Lot Numbers: 23CBV894, 23EBM160, 23FBI594, 23GBK013, 23HBW722; e) REF SUT13535, UDI/DI 40193489440271 (case), 10193489440270 (unit), Lot Numbers: 22FBG265, 22FBU120, 22HBK650, 22LBS268, 23CBH315, 23EBH269, 23HBU983; f) REF UVT840A, UDI/DI 653160292008 (case), 10653160292005 (unit), Lot Numbers: 22ABH461, 22ABJ736; g) REF DYNDA2369A, UDI/DI 00653160352160 (case), 10653160352167 (unit), Lot Numbers: 2022051050, 2022072750; h) REF DYNDC2869B, UDI/DI 20193489111719 (case), 10193489111712 (unit), Lot Numbers: 2021121750, 2022010450; i) REF DT20900A, UDI/DI 00653160353211 (case), 10653160353218 (unit), Lot Numbers: 2022061380, 2022061480, 2022082280; j) REF DYNDA2660A, UDI/DI 00653160351897 (case), 10653160351894 (unit), Lot Numbers: 2022042580, 2022050280, 2022082280; k) REF DYNDH1650, UDI/DI 20193489110866 (case), 10193489110869 (unit), Lot Numbers: 2022012050; l) REF DYNDC2816C, UDI/DI 00653160348309 (case), 10653160348306 (unit), Lot Numbers: 2022041880; m) REF EBSI1302A, UDI/DI 20193489111894 (case), 10193489111897 (unit), Lot Numbers:2022020250, 2022022880, 2022082280; n) REF DYNDC3188, UDI/DI 00653160348828 (case), 10653160348825 (unit), Lot Numbers: 2022012450; o) REF DYNDA2659A, UDI/DI 00653160351880 (case), 10653160351887 (unit), Lot Numbers: 2022042850; p) REF DYNDS1085A, UDI/DI 40080196778691 (case), 10080196778690 (unit), Lot Numbers: 2022041150, 2022051350, 2022053150

Quantity: 21154 units

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Recall record

Recall number: Z-1112-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Recall initiated: 2023-11-15
Classified by FDA Center: 2024-02-24
FDA published: 2024-03-06
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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