Reported Nov 27, 2013 · Terminated
Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT,…
Stryker Sustainability Solutions
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: Stryker Sustainability Solutions · 1810 W Drake Dr · Tempe, AZ · 85283-4327
Is this the product you have?
- Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables
- Model Numbers
D6-DR-252-RTF6-QF-252RT201101201104401442401860D7-A20-131-RT401661401972401977401981401982C6-MR/MST4-SACB3434CT
- Product UsageReprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures
- NoteThese devices do not support or sustain life. Diagnostic EP Catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables interface an EP catheter with the appropriate external stimulation or recording equipment or serve as an extension cable between an EP catheter and equipment out of immediate reach. Reprocessed diagnostic electrophysiology catheter cables are indicated for use with the appropriate electrode catheter during electrophysiology studies
- Lot codes and dates
- Lot/Serial numbers
152965215355481538579153865515624181562420156843415684781596050125847515960511535068153507115350721559331136312314060411531413153337815333851535540159604715960481471197153956015395611541119159604975789516008791520424155882615588271600880160088115581031434511146498716008821313231160088316008841401578157096416006701600671
- Lot/Serial numbers
- Amount recalled
- 46 units total
Where it was sold
Why it was recalled
Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) Catheters Cables due to a potential sterility breach in the package seal.
This product could cause temporary or reversible health problems — stop using it.
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