Medline Prep Kits Recalled Due to Non-Sterile Components
Medline is recalling 1,270 prep kits containing components that may lack sterility. Solutions from Nurse Assist used in the kits may not be sterile.
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: This is an FDA Class I recall, which per agency guidelines requires a minimum severity classification of Severe. The potential lack of sterility in medical components presents a serious health risk despite no reported adverse events.
Plain-English summary
Medline Industries, LP is recalling 1,270 kits, trays, and packs. The recalled products include C L PREP (REF DYNJ69664), DMEK PREP PACK (REF DYNJ81659A), and two variants of PRE OP KIT 1 (REF DYKS1377 and DYKS1377A). Specific lot numbers have been identified for each product type.
The recall was initiated because components supplied by Nurse Assist may lack sterility. The affected components include 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. If these components are not sterile, the kits may be non-sterile when used.
These products were distributed nationwide in the United States, including Puerto Rico, as well as to Canada, the United Arab Emirates, and Panama. Individuals and organizations in possession of these kits should contact Medline Industries, LP for information about returns or other remedial actions.
The recalled product
- Product
- Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; c) PRE OP KIT 1, REF DYKS1377; d) PRE OP KIT 1, REF DYKS1377A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 1,270
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 (18)
- a) REF DYNJ69664
- UDI/DI 40193489966337 (case)
- 10193489966336 (unit)
- Lot Numbers: 21LBW095
- 22EBT126
- 22HBQ767
- 22LBB063
- 23EBF143
- b) REF DYNJ81659A
- UDI/DI 40195327277094 (case)
- 10195327277093 (unit)
- Lot Numbers: 22KBK040
- c) REF DYKS1377
- UDI/DI 40195327216673 (case)
- 10195327216672 (unit)
- Lot Numbers: 22LLA282
- d) REF DYKS1377A
- Lot Numbers: 23BLA389
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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