Medline Tracheostomy Care Kits Recalled for Non-Sterile Component Solutions
Medline Industries is recalling care and cleaning kits for tracheostomy and stomas due to component solutions that may not be sterile. The affected kits contain Nurse Assist-manufactured saline and irrigation solutions distributed in the U.S., Puerto Rico, Canada, UAE, and Panama.
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 represents the highest regulatory risk category for medical devices. Per the severity criteria, FDA Class I recalls are classified as Critical, and this classification is never to go below 4 regardless of reported injury status.
Plain-English summary
Medline Industries, LP is recalling certain care and cleaning kits and trays for tracheostomy and stoma care manufactured with component solutions from Nurse Assist. Nurse Assist issued a recall of these component solutions—0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe—due to the potential lack of sterility. The affected Medline products include: STOMA & TRACH CLEANING KIT (REF DYNDJ1129), TRACH CARE TRAY (REF DYNDJ1057A), TRACHEOSTOMY CARE KIT (REF DYNDA1893A), and TRACH CARE TRAY (REF DYNDA1482). A total of 2,683,387 units have been distributed to the United States, Puerto Rico, Canada, the United Arab Emirates, and Panama.
The component solutions could be non-sterile, which presents a potential infection risk in medical procedures performed on sensitive sites. Consumers who have affected kits should discontinue use and contact Medline Industries or their healthcare provider for guidance on replacement or disposal. Affected lot numbers and product identifiers are listed in the FDA recall notice for identification.
The recalled product
- Product
- MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT, REF DYNDJ1129; b) TRACH CARE TRAY, REF DYNDJ1057A; c) TRACHEOSTOMY CARE KIT, REF DYNDA1893A; d) TRACH CARE TRAY, REF DYNDA1482
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device
- Hazard
- Affected units
- 2,683,387
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 DYNDJ1129
- UDI/DI 40195327391400 (case)
- 10195327391409 (unit)
- Lot Numbers: 23EBD895
- 23EBD896
- 23EBD897
- 23GBQ880
- b) REF DYNDJ1057A
- UDI/DI 40888277204790 (case)
- 10888277204799 (unit)
- Lot Numbers: 23ABA019
- 23EBM580
- 23HBU078
- c) REF DYNDA1893A
- UDI/DI 40193489866125 (case)
- 10193489866124 (unit)
- Lot Numbers: 23CBA077
- 23CBI537
- 23CBT627
- 23DBF373
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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