Medline Kits recall: Sterility Concern
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;
Why was Medline Kits recalled?
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.
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?
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
- Product
- 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;
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 21154 units
- Distribution
- Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
- Recall date
- March 6, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)