Medical DeviceMar 1, 2017
Custom Medical Specialties CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD recall — FDA Z-1234-2017
Sterility of syringe product could not be assured.
Class IIFDA: OngoingCustom Medical Specialties, Inc.
Recall history in this database
Classification mix: Class II: 4.
DrugAug 29, 2012
Custom Medical Specialties CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains recall — FDA D-1651-2012
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.
Class IIFDA: TerminatedCustom Medical Specialties, Inc.
DrugAug 29, 2012
Custom Medical Specialties CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium recall — FDA D-1650-2012
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.
Class IIFDA: TerminatedCustom Medical Specialties, Inc.
DrugAug 29, 2012
Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order # recall — FDA D-1649-2012
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
Class IIFDA: TerminatedCustom Medical Specialties, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Custom Medical Specialties, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.