MEDLINE Surgical Kits Recalled Due to Potential Sterility Failure
MEDLINE is recalling surgical kits, trays, and packs due to potential lack of sterility in component solutions. The recalled products were distributed nationwide and internationally.
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 recall is classified as FDA Class I. Per the rubric, FDA Class I medical device recalls carry a minimum severity score of 4 (Severe), even absent reported illnesses or injuries.
Plain-English summary
MEDLINE Industries, LP is recalling certain surgical kits, trays, and packs used in medical procedures. These products contain component solutions from Nurse Assist: 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. The recall was initiated due to a potential lack of sterility in these components.
The recalled MEDLINE products include: ENDO KIT (REF DYKE1350D), PANENDOSCOPY-LF (REF DYNJ36728C), and UMBILICAL VESSEL INSERTION kits (REF UVT1170 and UVT1170H). The products have been distributed nationwide across the United States, including Puerto Rico, and internationally to Canada, United Arab Emirates, and Panama.
This is an FDA Class I recall (number Z-1106-2024).
The recalled product
- Product
- MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C; c) UMBILICAL VESSEL INSERTION, REF UVT1170; d) UMBILICAL VESSEL INSERTION, REF UVT1170H
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Affected units
- 1,184
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 DYKE1350D
- UDI/DI 40193489339797 (case)
- 10193489339796 (unit)
- Lot Numbers: 22FBT089
- 22LBN853
- 23CBI535
- 23DBQ149
- 23EBI601
- b) REF DYNJ36728C
- UDI/DI 40193489265911 (case)
- 10193489265910 (unit)
- Lot Numbers: 22BBJ543
- 22FBD924
- 22HBR956
- 23BBF230
- 23FBG752
- c) REF UVT1170
- UDI/DI 40653160991244 (case)
- 10653160991243 (unit)
- Lot Numbers: 21LBK307
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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