Surgical kits and trays recalled due to lack of sterility
Medline Industries is recalling over 3,200 surgical kits and trays containing components that may lack sterility. The recalled products could pose infection risk to patients if used during surgical procedures.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall, which indicates a potentially serious health hazard. The potential lack of sterility in surgical irrigation solutions could result in serious infections during medical procedures, directly supporting the FDA's Class I classification.
Plain-English summary
Medline Industries, LP is recalling 3,297 surgical kits, trays, and packs that were manufactured using specific lots of components from Nurse Assist, including 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. The recalled products are identified by multiple reference numbers (such as ASC GENERAL MINOR CDS, C NURSE BAG KIT, LAP CHOLE CDS, LAPAROSCOPY PACK, and others as listed in the FDA notice).
The recall was initiated due to potential lack of sterility in the Nurse Assist components. Non-sterile irrigation solutions could introduce bacterial contamination during surgical procedures where these kits are used.
The recalled kits were distributed nationwide across the United States, Puerto Rico, Canada, United Arab Emirates, and Panama. Healthcare facilities and surgical centers that received these products should verify their inventory against the FDA recall notice using the provided lot numbers and reference codes to identify affected units.
The recalled product
- Product
- MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G; b) ASC GENERAL MINOR CDS, REF CDS983673I; c) C NURSE BAG KIT, REF DYKM1425; d) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; e) GASTRIC CULTURE PACK, REF DYNJ53966A; f)…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 3,297
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 CDS983673G
- UDI/DI 40193489951746 (case)
- 10193489951745 (unit)
- Lot Numbers: 22EDA378
- 22EDB208
- b) REF CDS983673I
- UDI/DI 40195327147335 (case)
- 10195327147334 (unit)
- Lot Numbers: 22GBJ096
- 22GBJ097
- 22HBR769
- 22KBN934
- 23ABH521
- 23ABM586
- 23BBR709
- 23DBL344
- c) REF DYKM1425
- UDI/DI 40889942511236 (case)
- 10889942511235 (unit)
- Lot Numbers: 22DLA695
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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