Medline Port Removal Kits Recalled for Potential Sterility Loss
Medline Industries recalls certain port removal kits due to potential loss of sterility in irrigation solutions manufactured using specific component lots.
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 per the rubric. The recall involves potential loss of sterility in medical-grade irrigation solutions used in clinical procedures, creating a direct risk of infection.
Plain-English summary
Medline Industries, LP is recalling certain port removal kits and trays labeled as PORT REMOVAL PACK (REF DYNDA2936 and REF DYNDA2936H) that were manufactured using specific lots of Nurse Assist components, including 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe.
The recall was issued because these component lots may lack sterility, which could result in the irrigation solutions being non-sterile. Non-sterile solutions used in medical procedures could create a risk of infection.
The affected kits were distributed nationwide throughout the United States, including Puerto Rico, as well as to Canada, the United Arab Emirates, and Panama. The recalled lot number is 22FBQ167.
Healthcare facilities and medical professionals should discontinue use of the affected kits immediately. Contact Medline Industries with questions about the recall or product replacement.
The recalled product
- Product
- Medline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK, REF DYNDA2936; b) PORT REMOVAL PACK, REF DYNDA2936H
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 16
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 (5)
- a) REF DYNDA2936
- UDI/DI 40195327132577 (case)
- 10195327132576 (unit)
- Lot Numbers: 22FBQ167
- b) REF DYNDA2936H
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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