# FDA recall D-1650-2012

> **Custom Medical Specialties, Inc.** · Class II · drug recall initiated 2012-07-23.

## 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.

## 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.

## Distribution

GA, MD, MA

## Key facts

- **Recall number:** D-1650-2012
- **Recalling firm:** Custom Medical Specialties, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-07-23
- **Report date:** 2012-08-29
- **Termination date:** 2012-10-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pine Level, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1650-2012

## Citation

> AI Analytics. FDA recall D-1650-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1650-2012. Source: US FDA. Licensed CC0.

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