Medline procedure packs with Shenli syringes recalled for leaks and breakage
Medline is recalling medical procedure packs containing Shenli syringes due to identified leaks, breakage, and quality issues. These kits may pose a risk to patient health during surgical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 medical devices with confirmed defects (leaks and breakage) affecting high-risk surgical procedures. No illnesses or injuries have been reported. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported, warranting a High severity score.
Plain-English summary
Medline Industries is recalling 1,679,067 units of medical procedure packs containing Shenli syringes due to identified leaks, breakage, and quality issues. The affected kits include neuro angiography packs, central venous catheter insertion bundles and kits, and related procedure sets distributed worldwide.
The FDA issued a Safety Alert on March 19, 2024, regarding these syringes. The leaks, breakage, and other quality issues identified in the syringes may pose a risk to patient health during medical procedures.
Healthcare providers who have received any of the affected procedure packs should not use them. The specific part numbers and lot numbers of affected kits are available in the FDA recall notice.
The recalled product
- Product
- Medline procedure packs containing Shenli syringes, labeled as follows: 1) NEURO ANGIO PACK, Part Number DYNDA1431A; 2) CVC INSERT BUNDLE 16CM, Part Number ECVC3260; 3) CENTRAL LINE INSERTION KIT, Part Number ECVC7440; 4) CENTRAL LINE INSERTION KIT, Part Number…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 1,679,067
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)
- DYNDA1431A
- Lot Number 2019021190
- ECVC3260
- Lot Number 2019091850
- Lot Number 2019120950
- ECVC7440
- Lot Number 2021071950
- Lot Number 2021092150
- ECVC7445
- Lot Number 2021052850
- Lot Number 2021062250
- ECVC7445A
- Lot Number 2022012850
- Lot Number 2023010390
- ECVC8045
- Lot Number 2023031590
- ECVC8105
- Lot Number 2023112190
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 13 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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