Reported Aug 5, 2015 · Terminated
Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM…
EXP Pharmaceutical Services Corp.
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: EXP Pharmaceutical Services Corp · 48021Warm Springs Boulevard · Fremont, CA · 94539
Is this the product you have?
- Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number A-CRN-S; EXP (repackager), Anspach (OEM) Bur, surgical, general & plastic surgery
- Lot codes and dates
- OEM Catalog number A-CRN-S.
- Amount recalled
- 4
This recall covers 42 products
The agency filed one notice per product. You are reading one of them; the other 41 are below.
29 more are in the archive.
Where it was sold
Why it was recalled
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
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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