Medline Surgical Kits Recalled Due to Sterility Defect in Irrigation Solutions
Medline Industries recalls certain surgical kits and trays because irrigation solution components may lack sterility, creating potential infection risk.
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 medical device recall. FDA Class I recalls score at minimum 4 per the rubric. The potential for sterility failure in surgical irrigation solutions poses significant risk of infection during surgical procedures.
Plain-English summary
Medline Industries, LP is recalling certain surgical kits, trays, and packs labeled as C-SECTION (Reference DYNJ904653G) containing irrigation solution components. The recall affects 483 units manufactured using specific lot numbers (22KBM559, 22KBM896, 23CBU919) of components supplied by Nurse Assist: 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe.
The recall was issued due to potential lack of sterility in the irrigation solution components. Non-sterile irrigation solutions could pose a risk of infection to patients undergoing surgical procedures.
These kits have been distributed throughout the United States, including Puerto Rico, as well as internationally in Canada, United Arab Emirates, and Panama. Healthcare facilities and providers should immediately discontinue use of affected products and contact Medline Industries for return instructions.
The recalled product
- Product
- Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 483
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 (6)
- REF DYNJ904653G
- UDI/DI 40195327277660 (case)
- 10195327277659 (unit)
- Lot Numbers: 22KBM559
- 22KBM896
- 23CBU919
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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