ICU Medical, Inc. is voluntarily recalling one lot of 0.9% Sodium Chloride Injection, USP 1000 mL to the hospital/user level due to a confirmed customer complaint of particulate matter identified as stainless steel within a single flexible container.
Injection of particulate matter could potentially lead to limited adverse events such as allergic reactions, local irritation and inflammation in organs or tissues, or other serious adverse health consequences. Prior to administration, healthcare professionals, as instructed in the product labeling, should visually examine the product for particulate matter and discoloration and should discard if a defect is identified. The reported incident was identified prior to use, and there have been no reports of adverse events associated with this issue to date.
0.9% Sodium Chloride Injection, USP 1000 mL is an intravenous solution indicated for parenteral replenishment of fluid. The affected product lot was manufactured in the U.S. by Hospira, a Pfizer company, on February 1, 2016 and was distributed nationwide to Hospira customers between April 14, 2016 and February 2, 2017. The affected lot is:
| NDC Number | Lot Number | Expiration Date | Configuration/Count |
|---|---|---|---|
| 0409-7983-09 | 61-841-FW | January 01, 2018 | 1000mL Single Dose Flexible Container |
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
