Hummingbird Med Recalls Hummi Micro Draw Blood Transfer Devices
Hummingbird Med is recalling Hummi Micro Draw Blood Transfer Devices because the Y connector may separate from the cannula hub during use.
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: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Hummingbird Med Devices, Inc. is recalling ABG-HM-1 Hummi Micro Draw Blood Transfer because the connection between the "Hummi" Y connector and the yellow cannula hub may not be sufficiently secure enough and could separate while in use."
Plain-English summary
Hummingbird Med Devices, Inc. is recalling the ABG-HM-1 Hummi Micro Draw Blood Transfer Device. This medical device is used for blood transfer and collection from Peripheral Arterial Line Catheters.
The recall was initiated because the connection between the "Hummi" Y connector and the yellow cannula hub may not be sufficiently secure. This defect could cause the components to separate while the device is in use.
The affected units were distributed in the states of California, Kentucky, Maryland, Georgia, and Illinois. The recall covers 11,500 units from lots 15180, 15286, 15287, 15300, and 15305.
The recalled product
- Product
- ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection from Peripheral Arterial Line Catheters.
- Manufacturer
- Hummingbird Med
- Hazard
- Affected units
- 11,500
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 (5)
- Lot 15180
- 15286
- 15287
- 15300
- 15305
Distribution
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