MEDLINE Medical Device Kits Recalled for Potential Sterility Issues
Medline Industries recalls multiple medical device kits and trays manufactured with components that may lack sterility. The affected solutions could be non-sterile, posing a potential safety risk.
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: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"
Plain-English summary
Medline Industries, LP is recalling certain medical device kits and trays that were manufactured using specific components supplied by Nurse Assist. The affected products include breast biopsy trays and colon kits distributed under reference numbers DYNDH1679, DYNDH1664, DYNDH1431A, DYNJ46448, DYKE1520B, and DYNDH1808.
The recalled components include 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. These components were manufactured with a potential lack of sterility, which could result in non-sterile solutions being used in medical procedures.
The affected products have been distributed US nationwide, including Puerto Rico, Canada, the United Arab Emirates, and Panama. Patients and healthcare facilities that have received these products should not use them and should contact their healthcare provider or Medline Industries for instructions on proper handling and replacement.
The recalled product
- Product
- MEDLINE Kits, trays, and packs labeled as follows: a) Description, REF DYNDH1679; b) BREAST BIOPSY TRAY, REF DYNDH1664; c) BREAST BIOPSY TRAY, REF DYNDH1431A; d) BREAST BIOPSY TRAY, REF DYNJ46448; e) BREAST BIOPSY TRAY, REF DYKE1520B; f) COLON KIT- BERLIN, REF…
- 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 DYNDH1679
- UDI/DI 40653160991534 (case)
- 10195327007041 (unit)
- Lot Numbers: DYNDH1431A
- b) REF DYNDH1664
- UDI/DI 40193489993930 (case)
- 10193489993929 (unit)
- Lot Numbers: DYNDH1664
- c) REF DYNDH1431A
- UDI/DI 40889942880486 (case)
- 10889942880485 (unit)
- Lot Numbers: DYNDH1679
- d) REF DYNJ46448
- UDI/DI 40888277261465 (case)
- 10888277261464 (unit)
- Lot Numbers: 23ADA841
- e) REF DYKE1520B
- UDI/DI 40193489374958 (case)
- 10193489374957 (unit)
- Lot Numbers: 22ABB336
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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