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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class I recall involving a risk-of-harm product where potential sterility defects could affect patient safety. However, no illnesses or injuries have been reported, and the hazard is potential rather than confirmed, which limits the score to 3 per the rubric.
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 DYNDH1
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterility-defect
- contamination-risk
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
Distributed nationwide across the United States.
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