ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in
FDA device recall Z-2659-2014 · posted 2014-09-17 · Terminated
Recall details
- Recalling firm
- Bio-Detek, Inc.
- Reason for recall
- Sterility of device is not assured
- Action taken
- BioDetek sent an Urgent Device Correction letter dated August 26, 2014, to all affected customers via UPS overnight delivery. There has also been notifications addressed to the 4 International accounts on August 27, 2014. Customers were requested to return the suspect product(s) in their possession and complete the Device Correction Response Return Form provided to each customer. Customer inventory will be replaced as soon as replacement electrodes are processed. Customers with questions can contact the technical support numbers at 1 (800) 348-9011 or +1 (978) 421-9460 24/7. For questions regarding this recall call 401-729-1400.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 12 each
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, and Germany.
- Date initiated
- 2014-08-26
- Date posted
- 2014-09-17
- Date terminated
- 2016-05-03
- Location
- Pawtucket, RI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES (K943698) | Zoll Medical Corp | 1994-12-28 |