Multi-event July 2012 FDA Recall Drug by Custom Medical Specialties, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Custom Medical Specialties, Inc. on July 23, 2012 for the product Drug. The FDA reported the reason for recall as 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.. The product was distributed in GA, MD, MA and the recall is currently terminated.

Reported Recall Events

D-1651-2012 TERMINATED D-1650-2012 TERMINATED D-1649-2012 TERMINATED

Recall Number: D-1651-2012

Reason for Recall
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.
Initiated
07-23-2012
Reported
08-29-2012
Quantity
25 Trays

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62775
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Custom Medical Specialties, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
FAX
Distribution Pattern About Distribution Pattern
General area of initial distribution.
GA, MD, MA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-11-2012
Product Description About Product Description
Full technical description of the product.
CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Manufactured by: CMS 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.

Batch or Lot Expiration Information

Lot# : 26124-1112, Exp 12/2012

Recall Number: D-1650-2012

Reason for Recall
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.
Initiated
07-23-2012
Reported
08-29-2012
Quantity
20 Trays

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62775
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Custom Medical Specialties, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
FAX
Distribution Pattern About Distribution Pattern
General area of initial distribution.
GA, MD, MA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-11-2012
Product Description About Product Description
Full technical description of the product.
CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: CMS, 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.

Batch or Lot Expiration Information

Lot# : 25915-1111, Exp 12/2012

Recall Number: D-1649-2012

Reason for Recall
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
Initiated
07-23-2012
Reported
08-29-2012
Quantity
35 Trays

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62775
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Custom Medical Specialties, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
FAX
Distribution Pattern About Distribution Pattern
General area of initial distribution.
GA, MD, MA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-11-2012
Product Description About Product Description
Full technical description of the product.
Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CMS-1667-R2(94-2478), Manufactured for KM Medical, Inc., 124 Jewett Street, Georgetown, MA 01833, the tray also contains other components not listed in this product description.

Batch or Lot Expiration Information

Lot# : 25744-1111, Exp 09/2012