ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 Product Usage: T
FDA device recall Z-0054-2015 · posted 2014-10-09 · Terminated
Recall details
- Recalling firm
- Bio-Detek, Inc.
- Reason for recall
- Product sterility is not assured
- Action taken
- Bio-Detek notiifed customers of the expanded recall on September 16, 2014 for Lot 1914 and September 22, 2014 for Lots 1614, 1814, 2114 via UPS overnight delivery. Customers were requested to return the suspect product(s) in their possession. A Device Correction Response Return Form was provided to each Customer. For questions call 1-800-348-9011 or 1-978-421-9460.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 193 cases (6/case)
- Distribution
- Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.
- Date initiated
- 2014-09-16
- Date posted
- 2014-10-09
- 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 |