CLASS I ONGOING Device recall · Reported 6 Mar 2024 · FDA Enforcement Report
Medline Tray care and cleaning kits and trays recalled
MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Tray care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a), distributed nationwide in the US. The recall was initiated on 15 Nov 2023 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1091-2024
- FDA event ID
- 93800
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 15 Nov 2023
- FDA classified
- 24 Feb 2024
- Reported
- 6 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 15 Nov 2023 | Recall initiated by company | |
| 24 Feb 2024 | Classified by FDA | +101 days |
| 6 Mar 2024 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Questions about this recall
Is Medline Tray care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) recalled?
Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline Tray care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) on 15 Nov 2023. The recall is Class I and its status is Ongoing. Recall number Z-1091-2024.
Why was it recalled?
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
Which lots are affected?
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, 23EBM582, 23HBV368, 23JBP946; d) REF DYNDA1482, UDI/DI 40889942131151 (case), 10889942131150 (unit), Lot Numbers: 2022040690, 2022052390, 2022102090, 2023011790
Where was it sold?
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS I | Medline medical convenience kits labeled as recalled | MEDLINE INDUSTRIES, LP - Northfield | Device Malfunction | 6 states |
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| Device | CLASS II | Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
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