Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics UPN/Prod
FDA device recall Z-1137-2017 · posted 2017-02-03 · Terminated
Recall details
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Reason for recall
- The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not properly manufactured. The affected product is not soldered per specification, and may result in the device not properly conducting the ECG signal.
- Action taken
- On 9/7/2016, AngioDynamics, Inc. sent URGENT VOLUNTARY MEDICAL DEVICE RECALL Notifications (dated 9/7/2016) to 47 consignees via Federal Express. Consignees were instructed to segregate and return all affected devices to AngioDynamics and complete and return the Reply Verification Tracking Form, provided in the recall notification. Please call AngioDynamics Customer Service at 1-800-772-6446 Monday - Friday between 8:00 am and 7:00 Pm EST to obtain a replacement or credit for returned product.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- LJW
- Distribution
- AZ, CA, FL, GA, IL, IN, KS, MD, MO, MT, NC, NJ, NV, OH, OR, PA, TN, TX, WI
- Date initiated
- 2016-09-07
- Date posted
- 2017-02-03
- Date terminated
- 2017-04-06
- Location
- Glens Falls, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Celerity PICC Tip Confirmation System (K142889) | AngioDynamics, Inc. | 2015-01-27 |
| CELERITY SYSYEM (K140799) | Medcomp (Medical Components, Inc.) | 2014-06-13 |