Reported Sep 24, 2014 · Terminated
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 These MFE…
Bio-Detek, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bio-Detek, Inc. · 525 Narragansett Park Dr · Pawtucket, RI · 02861-4323
Is this the product you have?
- ZOLL Pro-padz Sterile Adult Multi-Function Electrodes
- with 10-ft (3 m) leadwires Part number8900-4052 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring
- Lot codes and dates
- Lot Number2314
- Amount recalled
- 100 cases =600 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Sterility of device is not assured
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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