Medline Kits recall: Sterility Concern
Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, REF DYNDA2863; b) PORT ACCESS TRAY, REF DYNDA2863H; c) ULTRASOUND GUIDED IV…
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 DYNDA2863, UDI/DI 40195327008025 (case), 10195327008024 (unit), Lot Numbers: 22ABQ171, 22ABT619, 22IBG373; b) REF DYNDA2863H, UDI/DI 40195327008025 (case), 10195327008024 (unit), Lot Numbers: 22ABQ171, 22ABT619, 22IBG373; c) REF DYNDV2518, UDI/DI 40195327089079 (case), 10195327089078 (unit), Lot Numbers: 22GBA169, 22HBU208; d) REF DYNDV2518H, UDI/DI 40195327089079 (case), 10195327089078 (unit), Lot Numbers: 22GBA169, 22HBU208; e) REF DYNDV2445, UDI/DI 20193489110576 (case), 10193489110579 (unit), Lot Numbers: 2022012480; f) REF EBSI1306A, UDI/DI 00653160352122 (case), 10653160352129 (unit), Lot Numbers: 2022042850; g) REF BSIPIV1010, UDI/DI 00653160349153 (case), 10653160349150 (unit), Lot Numbers: 2022020750, 2022040480, 2022082980; h) REF DYNDV2465, UDI/DI 20193489110163 (case), 10193489110166 (unit), Lot Numbers: 2022031480, 2022041880
- Product
- Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, REF DYNDA2863; b) PORT ACCESS TRAY, REF DYNDA2863H; c) ULTRASOUND GUIDED IV…
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 3900 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)