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ffs/bench/fda/recall.json
Michael Greenberg 6ed74ee0c7
Timing support (#46)
Benchmarks, in two flavors: real-world benchmarks and synthetic microbenchmarks.

`--time` flag for benchmarking output on stderr.

Using R to generate pretty graphs. Some overhaul of build scripts and artifacts, with the hope of simplifying the release system.
2021-07-29 17:55:53 -07:00

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{
"meta": {
"disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
"terms": "https://open.fda.gov/terms/",
"license": "https://open.fda.gov/license/",
"last_updated": "2021-07-11",
"results": {
"skip": 0,
"limit": 1,
"total": 348
}
},
"results": [
{
"event_date_initiated": "2019-05-17",
"city": "Reading",
"address_1": "2400 Bernville Rd",
"reason_for_recall": "Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner.",
"product_code": "FOZ",
"code_info": "Lot/Batch Numbers: 13F18C0374, 13F18H0580, 13F18D0504, 13F18L0507,  13F18E0380, 13F18L0714, 13F18G0180, 13F18L0936,  13F18G0480",
"product_quantity": "3,143",
"additional_info_contact": "Customer Service\n866-396-2111",
"action": "On May 17, 2019, Arrow International issued Urgent Medical Device and Acknowledgement notices to customers via courier service. \r\n \r\nCustomers should take the following actions:\r\n1. Place a copy of the notification with each unit of affected product currently in your inventory.\r\n2. After step (1) is complete, fill out the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com.\r\n\r\nDistributors should take the following actions:\r\n1. Place a copy of the notification with each unit of affected product currently in your inventory.\r\n2. Using the provided customer letter template and acknowledgement form, communicate the notification to any of your customers who have received product included within the scope of the notification.\r\n3. Have each of your customers who received the affected product return a completed acknowledgement form to you.\r\n4. Once you have finished collecting and consolidating all of the acknowledgement forms from your customers and placing a copy of the notification with each unit of affected product in your inventory, please completed the enclosed Distributor Acknowledgement Form and fax it to 1-855-\r\n419-8507, Attn: Customer Service or email it to recalls@teleflex.com. This will allow us to document completion of this field action\r\n\r\nIf you have any other questions, feel free to contact\r\nyour local sales representative or Customer Service at 1-866-396-2111.",
"distribution_pattern": "US Nationwide Distribution",
"k_numbers": [
"K900263"
],
"firm_fei_number": "2518433",
"state": "PA",
"product_description": "Pediatric Two-Lumen Central Venous Catheterization\nKit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502\n\nProduct Usage; Provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access",
"root_cause_description": "Employee error",
"event_date_created": "2019-10-07",
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"device_name": "Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days",
"medical_specialty_description": "General Hospital",
"regulation_number": "880.5200",
"device_class": "2"
},
"event_date_terminated": "2020-09-24",
"recalling_firm": "Arrow International Inc",
"product_res_number": "Z-0053-2020",
"recall_status": "Terminated",
"res_event_number": "82984",
"postal_code": "19605-9607"
}
]
}