Medline Medical Device Kits Recalled for Potential Sterility Loss
Medline Industries is recalling 26,171 kits and trays containing potentially non-sterile irrigation solutions and syringes supplied by Nurse Assist, which could pose risks if used in medical procedures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which by definition indicates a reasonable probability that use of the product could cause serious adverse health consequences. The potential loss of sterility in irrigation solutions and syringes used in medical procedures poses direct risk in clinical settings.
Plain-English summary
Medline Industries, LP is recalling certain medical device kits, trays, and packs manufactured using components from Nurse Assist. These components include 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringes. Approximately 26,171 units are affected by this recall.
Nurse Assist recalled these components due to potential lack of sterility. The solutions and syringes could be non-sterile, which raises concerns for patients receiving medical procedures where these products are used.
The recalled kits and trays were distributed nationwide throughout the United States as well as to Puerto Rico, Canada, the United Arab Emirates, and Panama. They are used in healthcare settings for medical procedures.
Users of these products should stop use and check lot numbers against the FDA recall notice. Those with affected products should contact Medline Industries or the FDA for instructions on return, replacement, or proper disposal.
The recalled product
- Product
- Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PACK, REF DYNJ53643C; c) BAG TRUNK STOCK KIT, REF DYKM1880; d) BEDSIDE BRONCH PACK, REF DYKE1601; e) BIOPSY TRAY, REF DYNDH1242; f) BRONCH KIT, REF DYKE18
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterility-loss
- contamination
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 DYNJ55960G
- UDI/DI 40193489917827 (case)
- 10193489917826 (unit)
- Lot Numbers: 23ALA126
- b) REF DYNJ53643C
- UDI/DI 40889942615354 (case)
- 10889942615353 (unit)
- Lot Numbers: 22CLA226
- 22ELA033
- 22GLA633
- 22JLA774
- 23BLA613
- 23ELA554
- 23FLA005
- c) REF DYKM1880
- UDI/DI 40193489807524 (case)
- 10193489807523 (unit)
- Lot Numbers: 22FLA285
- 23FLA657
- 23HLA920
Distribution
Distributed nationwide across the United States.
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