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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Hazard
- lack-of-sterility
- infection-risk
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
Distributed nationwide across the United States.
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