Vasoshield Syringe Packs Recalled Due to Chipping Ink Risk
Maquet Cardiovascular is recalling Vasoshield Syringe Packs (Model VH-5001) because ink on the syringe logo may chip, creating a risk of foreign body complications and embolic events. The recall affects 530 units in the United States and 215 units outside the United States.
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: This FDA Class II recall involves a medical device with serious potential hazards including embolic events. However, no illnesses or injuries have been reported to date, and the risk is theoretical, meeting the High severity criterion for risk-of-harm products without reported injury.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Vasoshield Syringe Packs, Model VH-5001, that were distributed nationwide in the United States, Japan, and Germany. The recall was initiated because ink on the Maquet logo printed on the syringe may chip off during use.
If ink particles chip off and become embedded in the syringe, they may enter the patient's vascular system when the injection is administered. This creates an unreasonable risk of patient harm through foreign body reaction, coronary embolic event, or peripheral embolic event.
The affected units are identified by the following serial numbers: 25147126, 25151632, 25152389, 25152964, 25163138, and 25162077. A total of 530 units were distributed in the United States and 215 units were distributed outside the United States.
The recalled product
- Product
- Vasoshield Syringe Packs, Model VH-5001
- Manufacturer
- Maquet Cardiovascular, LLC
- Category
- Medical Device
- Hazard
- ink-chipping
- foreign-body-reaction
- embolic-event
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 (7)
- UDI-DI: 00607567700468
- Serial Numbers: 25147126
- 25151632
- 25152389
- 25152964
- 25163138
- 25162077
Distribution
Distributed nationwide across the United States.
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