Medline surgical kits and trays recalled for sterility defects
Medline Industries recalls 5,969 surgical kits and trays that may lack sterility due to components from Nurse Assist. The non-sterile irrigation solutions could compromise product safety.
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. Per the severity rubric, FDA Class I recalls carry a minimum severity score of 4, regardless of reported illnesses. The hazard is potential lack of sterility in irrigation solutions used in surgical procedures.
Plain-English summary
Medline Industries, LP is recalling 5,969 surgical kits, trays, and packs that were manufactured using specific lots of Nurse Assist components. The recalled products include C-section kits, dressing trays, endoscopic kits, eye kits, laparoscopic cholecystectomy kits, and suture trays with various reference numbers.
The recall was issued by Nurse Assist due to potential lack of sterility in three components used in these products: 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. Non-sterile irrigation solutions could compromise the sterility assurance of the surgical kits.
The recalled products were distributed nationwide in the United States, including Puerto Rico, as well as in Canada, the United Arab Emirates, and Panama. Healthcare facilities and medical supply distributors should check their inventory using the provided reference numbers and lot information to identify any affected products.
The recalled product
- Product
- MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; c) ENDO KIT, REF DYKE1387; d) ENDO KIT, REF DYKE1364B; e) ENDO KIT, REF DYKE1892; f) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I; g) EYE KIT, REF…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 5,969
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 DYNJ904653G
- UDI/DI 40195327279951 (case)
- 10195327279950 (unit)
- Lot Numbers: 23ABE326
- b) REF M101426
- Lot Numbers: 23ABD269
- c) REF DYKE1387
- UDI/DI 40889942384007 (case)
- 10889942384006 (unit)
- Lot Numbers: 22FBC677
- 22FBU123
- 22HBA432
- 22JBG195
- 23ABF156
- 23BBE110
- 23CBG139
- 23CBU443
- d) REF DYKE1364B
- UDI/DI 40195327162734 (case)
- 10195327162733 (unit)
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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