Medline arthroscopy procedure kits recalled for defective plastic syringes
Medline is recalling arthroscopy procedure kits containing plastic syringes with defects including leaks and breakage. The syringes may pose a risk to patient health during surgical procedures.
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: FDA Class II recall of surgical syringes with identified quality defects (leaks, breakage) that may pose a risk to patient health. No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet occurred.
Plain-English summary
Medline Industries is recalling multiple arthroscopy procedure kits because the plastic syringes they contain are affected by an FDA Safety Alert issued March 19, 2024. The syringes have been identified with leaks, breakage, and other quality issues that may pose a risk to patient health.
The recall affects seven kit models with a total of 186 units distributed nationwide in the United States and Canada. Each kit model has specific pack numbers and associated lot numbers for product identification.
Healthcare facilities and surgical providers that received these kits are affected. The defective syringes in these procedure kits may pose a risk to patient health.
The recalled product
- Product
- Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2) ARTHROSCOPY PACK-LF, Pack Number DYNJ0390808F; 3) ARTHROSCOPY PACK-LF, Pack Number DYNJ23150J; 4) ARTHROSCOPY PACK-LF, Pack Number DYNJ21233O; 5) ARTHROSCOPY PACK-LF, Pack Number DYNJ21
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 186
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 (14)
- 1) Pack Number DYNJHS0101I: UDI/DI 10888277046412 (each) 40888277046413 (case)
- Lot Number 21LBA780A
- 2) Pack Number DYNJ0390808F: UDI/DI 10889942244591 (each) 40889942244592 (case)
- Lot Number 21JMG164A
- 3) Pack Number DYNJ23150J: UDI/DI 10888277742239 (each) 40888277742230 (case)
- Lot Number 21LMF991A
- 4) Pack Number DYNJ21233O: UDI/DI 10889942543878 (each) 40889942543879 (case)
- Lot Number 22GBQ106M
- 5) Pack Number DYNJ21233O: UDI/DI 10889942543878 (each) 40889942543879 (case)
- Lot Number 22JBA123Z
- 6) Pack Number DYNJ46435A: UDI/DI 10889942670901 (each) 40889942670902 (case)
- Lot Number 23LMG014A
- 7) Pack Number DYNJ50120D: UDI/DI 10195327195656 (each) 40195327195657 (case)
- Lot Number 22JBG571Z
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 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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