FDA recall D-1649-2012

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.

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1649-2012