Medline Suction Catheter Kits Recalled for Potential Sterility Defects
Medline Industries is recalling 1,012,700 suction catheter kits manufactured with irrigation solutions that may lack sterility. The recalled products are distributed nationwide and internationally.
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: This is an FDA Class I recall, which is issued for products where serious adverse health consequences are reasonably probable. Although no illnesses have been reported, non-sterile medical irrigation solutions used in patient care settings pose a significant infection risk.
Plain-English summary
Medline Industries, LP is recalling multiple models of suction catheter kits and trays manufactured with specific lots of Nurse Assist irrigation solutions (0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP) and Nurse Assist Saline Flush Syringes. The affected products are distributed nationwide in the United States, Puerto Rico, Canada, UAE, and Panama. A total of 1,012,700 units are involved in this recall.
The recall was initiated after Nurse Assist determined that certain lots of the irrigation solutions and syringe components may lack sterility. Non-sterile solutions could become contaminated and potentially cause infection in patients receiving these products.
Consumers and healthcare providers who have received these kits should stop using them immediately and contact Medline Industries for return or replacement instructions. Healthcare facilities should check their inventory against the provided lot numbers and product reference codes to identify and quarantine affected units.
The recalled product
- Product
- Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470; b) KIT,SUCTION CATH,12FR W/H20 12, REF DYND41471; c) KIT,SUCTION CATH,14FR W/SALIN, REF DYND40442; d) KIT,SUCTION CATH,14FR W/WATER, REF DYND41472; e) KIT,SUCTION…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 1,012,700
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 DYND41470
- UDI/DI 40080196033608(case)
- 10080196033607(unit)
- Lot Numbers: 2022042690
- 2022070690
- 2022090790
- 2022102590
- 2023051790
- b) REF DYND41471
- UDI/DI 40080196033622(case)
- 10080196033621(unit)
- Lot Numbers: 2022070190
- 2022072890
- 2022101090
- 2022121390
- 2022121990
- 2023022890
- 2023051890
- c) REF DYND40442
- UDI/DI 40080196032618(case)
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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