Medline Medical Kits Recalled Due to Potential Lack of Sterility
Medline is recalling approximately 3,900 medical device kits and trays nationwide due to potential sterility failures in irrigating solution components. The affected products may not be sterile, creating a risk of infection.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I medical device recall. According to the severity rubric, FDA Class I recalls warrant a Critical (5) rating, the most serious category of medical device recall.
Plain-English summary
Medline Industries, LP is recalling approximately 3,900 kits, trays, and packs used in medical settings. Affected products include Port Access Trays (REF DYNDA2863, DYNDA2863H), Ultrasound Guided IV Start Kits (REF DYNDV2518, DYNDV2518H, DYNDV2445, DYNDV2465), NICU Insertion and Dressing Change Tray (REF EBSI1306A), and PIV BSI Kit (REF BSIPIV1010).
The recall is due to a potential lack of sterility in certain component lots of irrigating solutions (0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe) that were used to assemble these kits. If these solutions are not sterile, they could introduce pathogens or contamination into patient care settings, creating a serious infection risk.
The affected products were distributed nationwide across the United States, including Puerto Rico, as well as internationally to Canada, the United Arab Emirates, and Panama. Healthcare facilities and medical providers should check their inventory against the specific lot numbers listed in the recall.
If your facility received any of these products, immediately remove them from use and do not use them on patients. Contact Medline Industries for return authorization and replacement products. Report any adverse events or injuries related to these kits to Medline and the FDA MedWatch program.
The recalled product
- 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 START KIT, REF DYNDV2518; d) ULTRASOUND GUIDED IV START KIT, REF DYNDV2518H; e) KIT ULTRASOUND PIV START, REF DYNDV2445…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 3,900
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) REF DYNDA2863
- UDI/DI 40195327008025 (case)
- 10195327008024 (unit)
- Lot Numbers: 22ABQ171
- 22ABT619
- 22IBG373
- b) REF DYNDA2863H
- UDI/DI 40195327008025 (case)
- Lot Numbers: 22ABQ171
- c) REF DYNDV2518
- UDI/DI 40195327089079 (case)
- 10195327089078 (unit)
- Lot Numbers: 22GBA169
- 22HBU208
- d) REF DYNDV2518H
- UDI/DI 40195327089079 (case)
- e) REF DYNDV2445
- UDI/DI 20193489110576 (case)
- 10193489110579 (unit)
- Lot Numbers: 2022012480
Distribution
Part of a larger recall action
This product is one of 49 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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