Medline Catheterization Kits Recalled for Potential Sterility Defect
Medline Industries is recalling catheterization kits for potential sterility defects in component irrigation solutions. Non-sterile solutions used in medical procedures could result in serious infections.
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 requires a minimum severity score of 4. The hazard involves potential lack of sterility in medical irrigation solutions, which could cause serious infections in catheterization procedures.
Plain-English summary
Medline Industries, LP is recalling certain catheterization kits and trays containing Nurse Assist irrigation solutions manufactured with specific lots. The recalled product is CATHETERIZATION KIT, REF DYNDA2939, with UDI codes 40195327132492 (case) and 10195327132491 (unit). Lot number 22GBO521 is affected. The recall involves approximately 18 units.
The recall was initiated due to potential lack of sterility in the component solutions: 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe, all manufactured by Nurse Assist. Non-sterile solutions could result in serious infections when used in catheterization procedures.
The products were distributed nationwide in the United States, as well as to Puerto Rico, Canada, the United Arab Emirates, and Panama. Consumers who have received these kits should not use them and should contact their healthcare provider or Medline Industries for further instructions.
The recalled product
- Product
- MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF DYNDA2939
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 18
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 40195327132492 (case)
- 10195327132491 (unit)
- Lot Numbers: 22GBO521
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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