Reported Aug 29, 2012 · Terminated
CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: CMS, Custom Medical…
Custom Medical Specialties, 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: Custom Medical Specialties, Inc. · 330 East Main Street · Pine Level, NC · 27568
Is this the product you have?
CMS-8934 Custom Phlebectomy TraySterilecontains Sodium chloride 0.9% 50 mL
- Manufactured byCMS, Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine level, NC 27568, the tray also contains other components not listed in this product description
- Lot codes and dates
Lot #: 25915-1111Exp 12/2012
- Amount recalled
- 20 Trays
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
Why it was recalled
Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags.
This product could cause temporary or reversible health problems — stop using it.
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