Medline Medical Kits and Trays Recalled for Non-Sterile Solutions
Medline Industries is recalling multiple medical kits and trays containing irrigation solutions that may be non-sterile. The affected products are used in surgical and invasive procedures; non-sterile solutions could cause serious infections.
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, establishing a minimum severity score of 4. While no illnesses or injuries have been reported, the potential for serious adverse health outcomes is significant: non-sterile solutions in invasive surgical and medical procedures could introduce pathogens causing serious infections, bloodstream infections, and sepsis in vulnerable patients.
Plain-English summary
Medline Industries, LP is recalling numerous surgical and medical procedure kits, trays, and packs that contain specific lot numbers of irrigation solutions manufactured by Nurse Assist, including 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringes. These kits are used in a variety of invasive medical procedures, including central line insertions, PICC line placements, port access procedures, arterial line placements, and dressing changes on implanted medical devices.
The recall was initiated due to a potential lack of sterility in the irrigation solutions and components. If non-sterile solutions are used in surgical or catheter procedures, they could introduce bacteria or other pathogens into patients' bloodstreams or surgical sites, potentially resulting in serious infections including bloodstream infections and sepsis.
The affected products are distributed nationwide in the United States, as well as in Puerto Rico, Canada, the United Arab Emirates, and Panama. Multiple kits and trays with specific reference numbers and lot numbers are included in this recall, as detailed in the FDA recall notice.
Healthcare facilities and patients who have these kits should discontinue use immediately and contact Medline Industries for further instructions and possible replacements.
The recalled product
- Product
- MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KIT, REF DT22710; c) CAP CHANGE KIT, REF DYNDC2002A; d) CAP CHANGE KIT, REF DYNDC2723A; e) CAP CHANGE KIT, REF DYNDC2723B; f) CENTRAL LINE INSERTION…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
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 DYNJ65208A
- UDI/DI 40195327120598 (case)
- 10195327120597 (unit)
- Lot Numbers: 23CMB532
- 23CME753
- 23EMD721
- 23FMH948
- b) REF DT22710
- UDI/DI 40653160990636 (case)
- 10653160990635 (unit)
- Lot Numbers: c) REF DYNDC2002A
- UDI/DI 21LBV542
- 22CBM841
- 22IBG132
- d) REF DYNDC2723A
- UDI/DI 40193489999236 (case)
- 10193489999235 (unit)
- Lot Numbers: 22ABH235
- 22BBF113
- 22IBG479
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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