Medline Arterial Irrigation Bundles Recalled Due to Sterility Risk
Medline Industries recalls arterial irrigation bundles due to potential loss of sterility in Nurse Assist components, which could deliver non-sterile solutions for medical procedures.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4. Non-sterile medical irrigation solutions used in arterial access procedures present significant risk for infection and patient harm, though no illnesses are reported in the source.
Plain-English summary
Medline Industries, LP is recalling certain arterial irrigation bundles (Medline Arterial Bundle No Catheter, Reference ART995) that contain Nurse Assist component solutions. The affected components include 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringes manufactured in specific lots.
Nurse Assist issued a recall notification due to the potential lack of sterility in these solution components. Non-sterile irrigation solutions used in arterial access procedures could compromise patient safety by introducing microbial contamination.
The recalled bundles have been distributed nationwide in the United States, including Puerto Rico, as well as internationally to Canada, the United Arab Emirates, and Panama. The specific lot number 2022050650 is identified in this recall.
Medline Industries recommends that healthcare facilities and providers immediately cease use of affected bundles and quarantine any remaining stock. Contact Medline Industries directly for replacement or return instructions. Healthcare providers should assess whether patients who may have received these products require follow-up evaluation.
The recalled product
- Product
- MEDLINE ARTERIAL BUNDLE NO CATHETER, REF ART995
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
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 (3)
- UDI/DI 20193489190509 (case)
- 10193489190502 (unit)
- Lot Numbers: 2022050650
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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