Hummingbird Med Recalls Hummi Micro Draw Blood Transfer Devices
Hummingbird Med is recalling 62,400 Hummi Micro Draw Blood Transfer Devices distributed in California due to insertion difficulties.
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 the Hummi Micro Draw because of insertion difficulties."
Plain-English summary
Hummingbird Med Devices, Inc. is recalling the Hummi Micro Draw Blood Transfer Device. The device is used for blood transfer and collection from peripheral arterial line catheters.
The recall was initiated because of insertion difficulties. A total of 62,400 units were distributed in the state of California. The affected lot numbers are 20140510, 20140513, 20140516, 20140519, 20140603, 20140606, 20140609, 20140612, and 14299.
The source text does not specify further instructions for consumers or healthcare providers regarding the disposition of these devices.
The recalled product
- Product
- ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and collection from peripheral arterial line catheters.
- Manufacturer
- Hummingbird Med
- Hazard
- Affected units
- 62,400
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Hummingbird Med
See all →- SevereHummingbird Med Recalls Hummi Micro Draw Blood Transfer Devices
FDA (Devices) · 2016-06-01
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- ModerateMedtronic Accurian RF Ablation Cannula Recalled for Insertion Difficulty
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- ModerateMedtronic Accurian RF Ablation Cannula Recalled for Insertion Difficulty
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- ModerateMedtronic Accurian RF Ablation Cannula Recall for Insertion Difficulty
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