The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit
FDA device recall Z-0057-2017 · posted 2016-10-07 · Terminated
Recall details
- Recalling firm
- Circulatory Technology Inc
- Reason for recall
- Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
- Action taken
- The firm, Circulatory Technology Inc., sent an "Urgent: Device Recall" letter dated July 1, 2016 and response forms to their customers via email. The letter described the product, problem and actions to be taken. The letter instructed customers to immediately inspect their inventory visually for units with wrinkled or twisted balloons and quarantine. Customers were also advised to complete and return the response form via email to ytamari@cirtec.com. Customers with questions are asked to contact Yehuda Tamari at (516) 624-2424, Monday to Friday, 9:00 AM - 7:00 PM, EST.
- Root cause
- Use error
- Status
- Terminated
- Product code
- DTN
- Quantity affected
- 958 units
- Distribution
- US Nationwide Distribution to states of: AL, AR, CA, Washington, D.C., FL, GA, IA, IL, IN, KY, LA, MI, MS, NC, NJ, NY, OH, OK, PA, SC, TN, TX & VA.
- Date initiated
- 2016-07-01
- Date posted
- 2016-10-07
- Date terminated
- 2017-04-14
- Location
- Oyster Bay, NY
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BETTER-BLADDER (BB) (K981284) | Circulatory Technology, Inc. | 1998-08-12 |